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Each infantry division had three battalions of twelve M2 105mm howitzers, one battalion for each of the division’s three infantry regiments. The M2 105mm howitzer had a range about 12,000 meters (7.5 miles). The primary role of these guns was support of a designated infantry regiment, but they could also fire in support of other units. Range - the maximum distance your gun is still effective at. Stability - the recoil as you fire the gun (especially over extended periods). DMG - the damage dealt with every round that hits. The Division 2 weapons guide - stats, tips, opinions on every weapon. From in-depth stats and behaviours to explanations of the various Exotic weapons in The Division 2, we've got a lot to cover in this weapons guide. Feel free to use any of the links below to skip ahead to a section of your choosing. Target population The Pfizer vaccine has been authorized for use for people aged 16 and older, though the company has recently asked the FDA to change the label to allow children 12 and older to.

• The Division Difference Dmg To Target Out Of Cover Rangers
• The Division Difference Dmg To Target Out Of Cover Range Chart
• The Division Difference Dmg To Target Out Of Cover Ranges
• The Division Difference Dmg To Target Out Of Cover Ranger

(February 18, 1997)

All NDA, ANDA, and AADA Holders

Dear Sponsors:

On November 30, 1995, the Scale-up and Post-Approval Changes Guidance for Immediate Release Products (SUPAC-IR) was published. Since then a number of questions have arisen in interpreting the Guidance as it applies to specific situations encountered or that could be encountered in the pharmaceutical industry. The purpose of this letter is primarily to share with you the questions that have been asked most frequently or that we consider the most significant. Also included are the Center's responses to these questions. The responses were developed and concurred with by the Office of New Drug Chemistry and Office of Generic Drugs, Center for Drug Evaluation and Research (CDER). We believe the sharing of the information will result in furthering the use of the Guidance to increase regulatory flexibility for industry.

In addition, the Center's Chemistry and Manufacturing Controls Coordinating Committee (CMC CC) has met and reconsidered two SUPAC-IR issues which have been of great concern and interest to industry. The following information on stand alone packaging operation site changes and stand alone analytical site changes represents a re-assessment of how SUPAC-IR should be interpreted on these issues.

STAND ALONE PACKAGING OPERATIONS SITE CHANGES

For immediate release solid oral dosage forms, a stand alone packaging operations site change, utilizing container(s)/closure(s) in the approved application, may be submitted as a Changes Being Effected supplement. The facility should also have a current and satisfactory cGMP compliance profile with FDA for the type of packaging operation in question before submitting the supplement. The supplement should contain written certification from the packaging facility stating that it is in conformance with cGMP's. If the facility has not received a satisfactory cGMP inspection within the previous two years for the type of packaging operation involved, a prior-approval supplement with the same commitment for stability is recommended.

The supplement should also contain a commitment to place the first production batch of the product on long-term stability studies using the approved protocol in the application and to submit the resulting data in annual reports. Where the product is available in more than one strength, size, or container/closure system, one batch of each combination should be placed on long-term stability studies. Bracketing or matrixing is allowed only if it has been approved previously by FDA. Any changes to an approved stability protocol should have a supplemental approval prior to the initiation of the stability study. Batches should be tested annually as per the stability commitments in the approved application.

STAND ALONE ANALYTICAL TESTING LAB SITE CHANGES

For immediate release solid oral dosage forms, a stand alone analytical testing laboratory site change may be submitted as a Changes Being Effected supplement, if the new facility has a current and satisfactory cGMP compliance profile with FDA for the type of testing operation in question. The supplement should contain a commitment to use the same SOP's and test methods employed in the approved application, written certification from the testing laboratory stating that they are in conformance with cGMP's, and a full description of the testing to be performed by the testing lab. If the facility has not received a satisfactory GMP inspection within the previous 2 years for the type of testing involved, a prior-approval supplement is recommended.

The CMC CC and the Center intend that the SUPAC-IR Guidance will be revised to further clarify and update its recommendations and to assure good correspondence between these recommendations and those of other SUPAC documents in preparation. In the meantime, we hope these questions and answers will help clarify the application of the Guidance.

Sincerely yours,

/s /

Roger L. Williams, M. D.
Deputy Center Director for Pharmaceutical Science
Center for Drug Evaluation and Research

Enclosure

SUPAC-IR: QUESTIONS AND ANSWERS

(To the extent these questions and answers provide guidance, that guidance was prepared by the Chemistry, Manufacturing, and Controls Coordinating Committee in the Center for Drug Evaluation and Research (CDER) at the Food and Drug Administration. Although this guidance does not create or confer any rights for or on any person and does not operate to bind the FDA or the industry, it does represent the Agency's current thinking on questions related to the Scale-Up and Post-Approval Changes Guidance for Immediate Release Products (SUPAC-IR). An electronic version of these questions and answers are also available via Internet using the World Wide Web (WWW). To access the document on the WWW, connect to the CDER Home Page and go to the 'Regulatory Guidance' section.)

COMPONENT AND COMPOSITION CHANGES

1. Q: May one color be replaced with another by placing the batch on concurrent stability and reporting it in the annual report?A: A change from one color to another should be submitted as a prior approval supplement.2. Q: Can color be changed under SUPAC-IR?A: Yes. A change in color, either in amount or from one color to another, is a level 3 component and composition change which calls for a prior approval supplement. However, if the color is merely being removed, it is a level 1 change and can be reported in the next annual report.3. Q: What is the full definition of a change in 'technical grade' of an excipient? Does this only mean a change in excipient specifications that may impact functionality or does it include a change in supplier even if all applicable specifications remain the same? A: Technical grades of excipients differ in their specifications and intended use. Technical grades may differ in: 1) specifications and/or functionality; 2) impurities; and 3) impurity profiles. If a supplier of an excipient changes but its technical grade AND specifications remain the same, the agency should be notified in an annual report.4. Q: How does one apply SUPAC-IR to multifunctional excipients, e.g., starch?

A: SUPAC-IR composition changes are based on being able to define the use or action of the particular excipient in the product. This rationale should be included by the applicants as part of their original applications. Not all multifunctional excipients are listed in the guidance. However, if an excipient was utilized to provide multiple functions such as pregelatinized starch as a filler, starch as a disintegrant, starch paste as a binder, then the most conservative recommended change should be followed (e.g., for an excipient that is a filler, disintegrant and binder, the recommended limit for a Level 2 change is ' 0.5 percent, see page 7, SUPAC-IR). An applicant may wish to add an explanation of how the change will affect other functions of the excipient in the product. If this information was not included in the original application, the review division should be consulted before filing such a SUPAC change, either through a CBE or annual report.

5. Q: What is the reference source for defining the action of an inactive ingredient, for example, lubricant versus glidant? What if the action is defined differently in two sources?A: An applicant should be able to justify the choice and the basis for the selection of a particular excipient, i.e., its expected function in the drug product. It may be useful to cite a source. The action may depend on the specific product.6. Q: Does SUPAC-IR cover changes in granulating solution volume outside the range in an application?A: Changes in granulating solution volume are not covered under SUPAC-IR. Minor changes are considered as normal operating procedure and should be included in the executed batch record. However, if this represents a permanent change, such a change may be described in the annual report along with the data to justify that the formulation quality and performance (i.e., drug product is within the approved specifications) was not altered.7. Q: To what category does a change in granulation solvent in a wet granulation process belong?A: A change in granulating solvent (e.g., alcohol to water) would alter the composition of the drug product, both qualitatively and quantitatively, even though it may be removed during manufacture of the drug product. Because such a change may have significant impact on formulation quality and performance, it is a level 3 composition change that needs a prior approval supplement.8. Q: The NDA includes validated/approved ranges for excipients in the formulation. We would like to move the target formula amount of one of the fillers to the upper value in the range. Will this be a level 1 change in composition?A: All changes are predicated on the target approved in the original application or through a prior approval supplement for a formulation change. For products approved with only a range for an excipient, the target may be assumed to be the mid-point of the approved range. If the new target is within the validated range, the change will be a level 1 or 2 change depending on the specific excipient changed and the percent change (see the SUPAC-IR guidance document). The target originally approved remains the target of record; i.e., Level 1 or Level 2 component changes made under SUPAC- IR do not change the target. If the new target is not within the validated range, the proposed target will need a prior approval supplement.9. Q: When microcrystalline cellulose is increased by 5%, the tablet weight increases. Can this still be a level 1 change?A: After the SUPAC-IR change, if the new target weight is still within the range in the approved original application, it is a level 1 change. Otherwise, it is a Level 2 or 3 change, both of which are to be submitted as a prior approval supplement.10. Q: If one component in a formulation is decreased, must another be increased so that the final weight can remain the same?A: No. The amount of a single component in the formulation may be changed independent of any other changes. (See 9 above)

11. Q: It is my understanding that the development report should cover ranges of processing parameters. Further, the validation report should cover the target parameters for production. If this is true, when level 1 changes are made, how can the validation cover ranges? For future validation reports, is it acceptable to vary processing parameters to prepare for future SUPAC changes?

A: The validation report should cover the target production parameters; however, it is not restricted to these only. If a range is specific, it needs to be validated. This can involve manufacturing batches of product at the extremes of the desired range(s), with appropriate testing to assure that the extreme range batches continue to meet all quality attributes, including dissolution and possibly in vivo bioequivalence tests. For future validation reports, it is acceptable to vary processing parameters. However, it should be understood that the Center's chemists do not review validation data collected by applicants, post-approval, on the first three production batches, because such information is checked by the Field investigators as part of the cGMP requirements. Thus, a summary of validation data on the test (bioavailability/bioequivalence) batch(es) submitted in the original application for approval is the basis for setting acceptable ranges of processing parameters for manufacture of the IR dosage form. These data may include parameters such as mixing time, mixing speed, and blend assays. Thus, for future level 1 SUPAC-IR changes, applicants should use the approved validation ranges as described in the application.12. Q: What is the guidance to determine if a new drug falls into the category of narrow therapeutic range?

A: Appendix A of the SUPAC-IR guidance lists a number of such drugs. In addition, 21 CFR 320.338 describes how to determine if a drug falls into this category.

13. Q: Is a change in gelatin capsule size considered a SUPAC-IR component and composition change?A: Issues related to empty gelatin capsules are not covered in the SUPAC-IR guidance. Only the component categories discussed in the document are covered. Changes for other components should be submitted in accordance with the provisions of 21 CFR 314.70.14. Q: When making a component or composition change according to SUPAC-IR, and the approved application has a range and target for a specific component, does the range move when the target changes?A: No. The range remains the same even when the target changes. Such changes are predicated on the target approved in the original application or through prior approval supplement for a formulation change. Changes to the approved range should be made by prior approval supplements in accordance with the provisions of 21 CFR 314.70.15. Q: Are wetting agents covered under SUPAC-IR?A: No. Only components included in categories spelled out in the guidance qualify as SUPAC-IR changes. Thus, wetting agents are not covered.16. Q: Can inks be changed under SUPAC-IR? If so, how?A: If the new ink has been used in other approved products the change is allowed under SUPAC-IR as a level one change. Alternatively, if all of the components of the ink have been used in approved drug products, the switch also can be made under SUPAC-IR. A justification should be given; reference should be made to the approved product(s) where the ink and/or the components are already used.17. Q: Can inks be eliminated under SUPAC-IR?

A: Ink can be eliminated as a level 1 change.

MANUFACTURING SITE CHANGES

1. Q: Must the inspection which is required for a site transfer have been conducted for the same dosage form?A: Yes. 2. Q: What is the meaning of 'same environmental conditions'?A: 'Same environmental conditions' refers to such conditions as the same temperature range, the same humidity control range, and the same lighting intensity.3. Q: Is moving to/between contract manufacturers covered by SUPAC-IR?A: Yes. The guidance defines site changes as a change in location of the site of manufacture for both company-owned and contract manufacturing facilities.4. Q: If a foreign firm moves to a new manufacturing site (new building) how would they initiate the inspection of that facility?A: The answer is the same whether the new site is foreign or domestic. The submission of a supplement (changes being effected or prior approval) for the site change will trigger an inspection request from the reviewing division. The move to a new manufacturing site may qualify as a level 1 change in which case the proper submission would be an annual report. In either case an applicant could ask the Field to evaluate their facility. Any site change under SUPAC-IR calls for the new site to be in compliance with cGMP regulations. Should the firm wish to schedule an inspection prior to submission of the site change information to the application, a foreign firm should contact the Foreign Inspection Team in the Division of Manufacturing and Product Quality, Office of Compliance, CDER. Domestic firms should contact their local district office.5. Q: Some investigators have stated that any 483 observations (no matter how minor) means that the inspection is 'violative' for the company. Should a firm assume that if they receive a 483 observation that they are 'violative'?A: The districts use three classifications, NAI (no action indicated), VAI (voluntary action indicated), and OAI (official action indicated). Generally, a firm classified NAI has no findings or a few insignificant findings and is considered to be in compliance and therefore not violative. A firm classified VAI usually has several violations that can be significant if they are not corrected as soon as possible. If the corrections and commitments appear adequate the firm is not considered to be violative. Generally, when a firm is classified OAI the findings are significant and should result in some or all of the following: withhold approval of an application, a warning letter, or an injunction, seizure, and/or prosecution. A firm will remain OAI until they have corrected the deficiencies.6. Q: If a site change described in Section IV includes manufacturing, packaging, and testing together, is it covered?A: Yes.7. Q: When packaging (or testing) is the only part of the manufacturing process which is being moved, is this situation covered by SUPAC-IR?A: Yes. Originally, only packaging (or testing) site changes which were part of a site change for complete manufacturing operation as described in #1 above were covered by SUPAC-IR. However, that position was recently reassessed by FDA. Packaging or testing site changes separate from the rest of the manufacturing operation are acceptable under SUPAC-IR as described in the cover letter.8. Q: Does the Center require any communication from the Field when a company reports a site change in the annual report?A: The facility should have had a successful cGMP inspection within the past two years and the Center does not expect to hear from the Field at the time of submission of the annual report. A firm may request an assessment of a proposed site change from the appropriate FDA district office.9. Q: Does Section IV apply to the addition of facilities not previously listed, or is it limited to sites already listed in the location of operations section?A: SUPAC-IR section IV does include site changes to facilities not already listed in the NDA/ANDA/AADA. For CBE supplements, a new manufacturing site should have an acceptable cGMP status, as previously discussed.10. Q: Are build-outs (extensions of a building) considered a SUPAC-IR level 1 site change?A: At the current time, the Center's position is that build-outs qualify as level 1 site changes. The change should be reported in the annual report as long as the facility has had a satisfactory cGMP inspection within the last two years.11. Q: Is it possible to have a site change covered under SUPAC-IR when the change results in different/revised SOPs?A: If SOPs are different, the implication is that the manufacturing process has also changed. Thus, this site change is not covered under SUPAC-IR. A prior approval supplement is required under 21 CFR 314.70 (b) (2) (vi).12. Q: What is meant by 'personnel common to both manufacturing sites' under part IV. Manufacturing?

A: This means personnel 'already working on the campus who have suitable experience with the manufacturing process.'

MANUFACTURING PROCESS CHANGES

1. Q: If no range was established through validation studies for mixing time, is it possible to make a level 1 change in mixing times?A: This situation does not qualify as a level 1 change.2. Q: If a parameter is not specified in the application (e.g. mixing speed), and you want to change it, is the change within range or outside?

A: If the approved application does not contain the necessary details (e.g., mixing speed), and one wants to change the method of manufacture of the drug product (i.e., equipment and/or process with associated parameters), a prior approval supplement should be filed.

MANUFACTURING EQUIPMENT CHANGES

1. Q: When going from equipment of one scale to one which is 2 or 1/10 the scale, the operating parameters will always change (e.g., airflows will decrease, spray rates will decrease). It is unlikely that the parameters will have been previously validated. Therefore, it would appear that any such change will be a level 2 change. Please comment.

A: If a scale-down of the production batch to 2 or 1/10 the size is needed, operating parameters that would fall within the range established for manufacture of the test batch and the first three production batches (i.e., validation batches) will be regarded as a level 1 change. If they fall outside the validation ranges the change would be permitted under SUPAC IR as a level 2 change. Regardless, SUPAC IR does not address scale-down below 100,000 units.

2. Q: Is a change in mill screen size (to improve flow during formulation) a level 1 change?A: A screen size change to an alternate screen of the same design (holes) and operating principle (sifting) but different diameters to facilitate flow of powder will be regarded as a level 1 change, provided the alternate screen has not altered the particle size distribution of the screened material. Under such conditions, the information can be filed in the annual report.3. Q: Must the equipment be moved from the old site to the new one when the manufacturing site is changed?

A: A company need not move equipment for a SUPAC-IR site change. However, any equipment should be of the same design and operating principle as the old equipment, and the SOPs and formulation should be the same.

IN VITRO DISSOLUTION

1. Q: Can the equation for profile dissolution be used for comparing a generic product with the reference listed drug product?A: Yes. The equation can be used in this situation. However, under SUPAC-IR, dissolution testing is generally conducted on the applicant's product before and after a particular change is made.2. Q: For Case C testing, specific media are cited. Can other media or other pH's be used?A: The five media indicated for Case C dissolution testing are presented as examples only. Other media, as appropriate for a particular drug product, if properly justified, may be used. Such a situation could involve using different solution compositions to attain a certain pH, as well as some at different pH conditions.3. Q: For SUPAC-IR changes which require multi-point dissolution in several media, is this required of AA drug products? A: For AA drugs (i.e., those drugs identified in the Approved Drug Products With Therapeutic Equivalence Evaluations or the 'Orange Book' as not presenting bioequivalence problems) when the original application only required multi-point single medium dissolution testing for approval, then a multi-point single medium dissolution will be satisfactory where Case C is specified in the SUPAC-IR guidance.4. Q: The inclusion of 'n' in the f2 formula implies that the number and time of the pulls is left to the discretion of the FDA investigator. Choosing points late in the curve could insure a high f2. How will this be avoided?A: It is recommended that only one point past the plateau of the profiles be used.5. Q: Are the points for dissolution profiles listed in the document just guides, or do you expect to see those specific points? For a quickly dissolving drug, points at 10, 20, 30, and 40 may be more appropriate.A: The points listed should be considered to be examples. Others points can be used with justification. It is suggested that at least 4 points (other than zero), equally spaced, be utilized.6. Q: What options are available if f2 fails?A: If an applicant believes the profiles are similar even if dissolution profiles fail f2, the firm may present a scientific justification as to why the observed difference is not due to the proposed change, and could not have significant impact beyond what is normally seen for batches prepared without the change.7. Q: For case C testing, if all of the media are not ones typically used, must the dissolution procedure be validated using these media?A: Yes. All of the methods used should be validated.8. Q: What methods, other than Dr. Amidon's are acceptable?A: This is an evolving area or research. 'Extent of absorption' may be an appropriate alternative, as indicated in the guidance. Full documentation of permeability may require special clinical testing. Physicochemical and in vitro predictors of permeability are being assessed at the FDA. Pending availability of these methods, firms may rely on literature data from pharmacokinetic/mass balance studies that suggest high extent of absorption of a drug across the gastrointestinal mucosa. Absent this information, firms should assume that a drug substance has low permeability and follow the recommendations in the SUPAC-IR guidance accordingly. 9. Q: How exactly is the industry expected to determine or know the permeability of their drug?A: One source of permeability information is the current research being conducted and sponsored by FDA. This information, for other drugs, could be experimentally determined by an applicant. Other alternative methods, related to permeability, may also be useful.10. Q: Are we allowed to monitor the metabolites and sum all the components?A: For determination of extent of absorption related to permeability, it may be appropriate to consider the sum of all components. As described in the guidance, this is 'in the absence of documented instability in the gastro-intestinal tract.' In general, it is appropriate to sum all of the components if the formation of the metabolite occurs following permeation through the gastrointestinal mucosa.11. Q: What constitutes an acceptable in vivo/in vitro correlation? Does 'verified' mean validated?

A: Verified may be thought of as synonymous with validated. The Biopharmaceutics Coordinating Committee in CDER is developing guidance that addresses the general question. Pending availability of this guidance, firms should refer to published literature for information on establishing in vitro/in vivo correlations.

IN VIVO BIO STUDIES

1. Q: If the highest strength was the biobatch strength, and waivers were used for the other strengths, does supporting documentation for SUPAC-IR changes refer to all strengths? Does the answer differ depending on whether the strengths are dose/weight proportional?A: For SUPAC-IR bioequivalence recommendations, the recommended tests apply to all strengths. Regarding bio-requirements, the supporting documentation normally is needed for all strengths. If a bioequivalence study is recommended, then the compositional proportionality of the various strengths may determine if all strengths need to be tested for bioequivalence, or if a strength can be waived. However, this is not the standard comparison that is in the SUPAC-IR Guidance.2. Q: Will many small changes prompt the Agency to require a biostudy?A: Generally, a biostudy will not be requested simply because many changes which individually would not normally require a biostudy, are performed.3. Q: For SUPAC-IR changes which require an in-vivo bioequivalence test, is this requirement also intended for AA drugs which were exempt from bioequivalence testing when originally approved?A: The Center did not intend for SUPAC-IR to impose additional bioequivalence requirements for AA drugs beyond those in an original application. (AA drugs are those identified in the Orange Book as not presenting bioequivalence problems.) Therefore, if bioequivalence testing was not required originally, it will not be required under SUPAC-IR for AA drugs.

4. Q: Would an in vivo bioequivalence study be needed for an AAA@ or non-bioequivalence problem DESI drug even if it one would be needed according to SUPAC?

A: No, since that would conflict with the agency's current bioequivalence policy. 5. Q: When a bio study is required under SUPAC-IR, to what product should a generic product be compared - the Reference Listed Drug or the generic product approved prior to the SUPAC change.

A: An innovator product should be compared to itself. A generic should be compared to the reference listed drug for that drug product.

STABILITY/CHANGE IN BATCH SIZE

1. Q: When the documentation for a change is one batch on long term stability, is there a time limit between implementation of the change and initiation of the stability study?A: No. But the stability study should start as soon as possible after the drug product is prepared in the market container.2. Q: What is the stability requirement for a level 3 change involving a product with multiple strengths packaged in bottles and blisters? SUPAC-IR states one batch. Can we bracket?A: Testing and data collection involving the use of product bracketing are not the subject of SUPAC-IR. Bracketing may be used with prior approval of the Agency. The amount of data required depends on the type of change and whether or not there is a significant body of data available. If an applicant plans to bracket, the proposed protocol should be submitted to the Agency. This plan should include a protocol for each product. It should indicate all of the approved packaging configurations, and what strengths are approved for each of these. It also should include the approved stability test protocol.3. Q: Who determines how many batches are required for stability when the documentation requests 1-3?A: The answer will be dependent on the specific drug product and the amount of data already available. The appropriate review division should be contacted for further guidance.4. Q: When accelerated stability data are required, is that comparative data?

A: Yes. Historical data may be used for comparison.

MISCELLANEOUS ISSUES

1. Q: The recommended documentation for several SUPAC-IR changes indicates that 'batch records' or 'updated batch records' be submitted. Should copies of batch records be submitted with the appropriate filing? Is batch record defined as the actual blank floor work order or can another manufacturing process description be used? In which cases should the batch records be executed batch records?A: Wherever 'batch record' occurs in the SUPAC-IR guidance, it means executed batch records. These records should be submitted in the designated filing.2. Q: What does the Agency intend by 'notification of change'? Should there be a separate communication to the Agency in addition to the annual report?A: The Agency should be notified of changes by the appropriate submission as described in the guidance..3. Q: May a firm make a SUPAC-IR change immediately after approval of the original application, or is there a waiting period?A: There is no waiting period. SUPAC-IR changes may be made as soon as the application is approved provided the appropriate data are available and filing criteria are addressed.4. Q: When there is a time lag between when changes are made under SUPAC and the submission of the annual report, what evidence is needed to show that an appropriate change will be submitted in the next annual report? What will the FDA investigator expect to see?A: The regulations at 21 CFR 314.70 (d) govern the filing of annual reports. Changes are made according to the applicant's change policy/procedures; these are part of the cGMP requirements. Because all changes should be approved by the appropriate quality unit, some set of documentation (e.g., development protocols, validation runs, batch records, etc.) should exist before the change is made. The investigator would expect to see this documentation.5. Q: Should the information described under 'documentation' be submitted in the filing, or does having the appropriate information on site for the inspection satisfy the requirement?A: The documentation should be included in the designated filing regardless of whether a supplement (prior approval or changes being effected) or annual report is used.6. Q: Are changes such as tablet shape and size covered under SUPAC-IR?A: In general, changes involving size and/or geometry of the tablet are not covered under SUPAC-IR, and would need prior approval supplements. However, changes in thickness due to a composition change may be covered under SUPAC-IR 7. Q: What does the Center expect relative to validation for SUPAC-IR changes?A: A summary of the validation data should be included in submissions describing process changes.8. Q: What is meant by 'validated range'?A: Validated ranges mean the upper and lower limits are validated for a particular manufacturing process. An example of this is the time required during mixing of bulk powders which supports the minimum and maximum time needed to optimize mixing of the contents9. Q: Based on the SUPAC video, it appears that a certificate of analysis and dissolution data need not be submitted in annual reports, but should be held on site. Is this correct?A: These data should be submitted in the annual report.10. Q: A 'significant body of data' is mentioned in several places in the SUPAC-IR guidance. What does this mean?A: If an applicant for a new molecular entity has at least five years of post-approval manufacturing experience, or if the applicant for a new dosage that is an immediate release solid oral, has at least three years of post-approval manufacturing experience, the Center believes that a 'significant body of information' exists for that product.11. Q: In the SUPAC-IR guidance document, what is meant by a 'short period of time'?A: Because it is difficult to specify a single time frame which could be applied to all situations for drug products, the appropriate chemistry team leader should be consulted. Each situation will be defined on a case by case basis.12. Q: If a new dosage form of a product that has been marketed for a number of years is accepted for filing as a generic product through the suitability petition process, will it be considered to have a 'significant body of information'?A: No, it would not. As noted in the definition for significant body of information, a significant body of information is likely to exist after three years of commercial experience for new dosage forms.

Date created: February 19, 1997; last update: July 6, 2005

Submit Comments

Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All comments should be identified with the title of the guidance.

• Regulated Product(s)

  Topic(s)

See the Effects topic for basic effects information.

• 3Creating Effects - Player Characters
• 9Reference
  • 9.3Special Components
• 10Examples
• 11Automating Effects on NPCs

What is an Effect?

One of the most powerful features of the built in 5e ruleset is effects. It is also, judging by the number of forum posts, the area where most users find the learning curve steepest. In Fantasy Grounds an effect is anything which gives the character either a bonus or penalty of some kind to a dice roll they are about to make. In order for the effect to be properly executed the character must be on the Combat Tracker (CT) and either they or another actor must make a dice roll which involves the character. In other words effects are checked when a character attacks, does damage, makes a saving throw (including death saves) or makes an ability or skill check. Effects are also checked when that same character is attacked, or damaged or has a saving throw, ability check or skill check forced on them (such as from a spell).

Automatic Effects

Many effects are created automatically for you in the 5e ruleset by dragging and dropping from the source material such as the Player's Handbook. For example dragging spells into the actions tab will in almost every case create an effect. Where an effect is not created via this method the probability is very high that either the spell doesn't require an effect or Fantasy Grounds doesn't have a built in way to handle whatever the spell is trying to do. For example the spell 'Animal Messenger' doesn't require an effect since this spell and others like it are simply 'Theatre of the Mind' spells. As another example the spell 'Counterspell' won't create an effect either because Fantasy Grounds can't know what the difficulty class of the incoming spell might be. For more information see the 5E Character Sheet

In the case of NPCs effects appear on the Combat Tracker when the NPC is placed there either from the NPC list or from an encounter. This action causes Fantasy Grounds to attempt to parse the information contained in the NPC sheet and create the effects. Most of the standard NPCs from the Monster Manual will, when dragged to the Combat Tracker, create any necessary effects so that the DM can use them. Again, not everything will create an effect either because one isn't required or Fantasy Grounds doesn't have a way to create one. For more details see the 5E NPC Sheet and the section below on the wording used to create NPC effects.

Creating Effects - Player Characters

In the player Character sheet effects are created in the actions tab. An effect can be added to an existing power or if no power exists a new one can be created.

• Click on the 'Edit List' button at the bottom right hand side of the Actions Tab and then click on the 'star' icon to create a new power group. You can also right click on an existing power and select 'Create Item'
• Type a name into the new line where it says <<name>>. This will be the name of the action that you are going to create. You can also type into the right hand box to give the power group a name.
• Note that the Power Group now has a magnifying glass at the right hand side. You can click on this to bring up the power group dialog and here you set the ability which this power group will use for any attacks, saving throws and bonuses for all of the actions that you set within this power group.
• Now right click on the new line created above to bring up the radial menu and select 'Add Action'. This will bring up a submenu which allows you to create the following:
  • Add Cast: this allows for an attack roll to be made against the target or forces the target to make a saving throw - or both
  • Add Damage: As it's name suggests this allows for the creation of a damaging effect to apply to the target
  • Add Heal: Create a healing effect
  • Add Effect: This adds an effect to the target. This can be almost anything from applying a simple condition such as poisoned to a whole series of statements which might apply to the target.
• Whichever you choose a new line will be created with a small magnifying glass beside it. Click the magnifying glass to open up the dialogs associated with each effect type.

Cast Dialog

• The first section is concerned with attacks. Click the words under 'type' to cycle through the (self explanatory) options, ranged, melee or none.
• Under 'Base' click to cycle through the options:
  • Group Attack+: This refers to the Power Group and the base attack will feed off whatever the base attack has been set within the power group (see above). So if the Power Group ability has been set to STR then this attack will use the character's STR to determine any bonus or penalty to the attack roll.
  • Ability: This allows for setting an ability for this effect independent of whatever has been set for the Power Group. Click the 'Stat' field to cycle through the options. This includes all of the ability modifiers, classes, the character level (lvl) and the character's proficiency. This allows for extreme flexibility in setting up actions. Setting this to 'Base' will feed off the ability which has been set for the Power Group.
  • Fixed: Allows for entering a straightforward number. This is useful if the attack is not based off any particular ability, class or level. In this case enter the number desired in the 'bonus' box.
  • Bonus: Enter a number if any bonus is to be applied to this attack roll.
• The second section of this dialog is concerned with saving throws.
  • Type: Click to cycle through the options. For example if you want the target to make a DEX saving throw set this to 'Dex'. Once again 'Base' represents the ability set in the Power Group.
  • Base: This is the same as the 'Base' option described above in the attack section.
  • Bonus: Again this is the same as the bonus section in the attack section.
  • On Save: Click here to select 'Half on Success' if the creature takes only half damage on a successful saving throw.
• Once completed the effect will appear in the Actions tab ready for use. Clicking the small dice icon beside the effect will cause Fantasy Grounds to make the attack and/or saving throw against the target of the attack. Players can also perform the attack and save separately by clicking first on the little sword icon and then on the dice icon beside the save.

Damage Dialog

• Click the 'Edit List' button and then the green 'Add Item' button to create a new line.
• Drag dice and drop them into the 'Dice' box for the damage amount. For example if the damage is 2d6; click and hold a d6, then right click to add a second dice and then drop into the box below 'Dice'.
• Click on the box below 'Stat' to cycle through the options. Once again 'Base' will feed off whatever ability was set in the Power Group.
• Add any bonus to the damage if this is relevant. Note that this is not the bonus from the ability being used but any bonus that might be available from a magic weapon for example.
• Enter the type of damage that the effect will do. Note multiple damage types can be entered separated by a comma. You can also add magic, silver, adamantine or cold-forged if the damage has any of these tags.
• You can continue to add new lines for more damage if this is relevant.

Heal Dialog

• Select the target of the heal by clicking through the options in 'Targeting'. 'Self' will only heal the caster. Targets will heal any target selected including the caster if he is selected.
• Cycle through the options under 'Type'. 'TEMP' will give the target temporary hit points, 'HP' will remove wounds from any targets selected by the character using the cast.
• Click the 'Edit list' button and then the green 'Add Item' button to add a new line.
• Drag dice into the dice box in the same way as described above.
• Select a stat if appropriate in the stat box by clicking through the options. Again 'base' will use the ability from the power group. There are also options to add level, proficiency or class.
• Enter a figure for any bonus to the heal.
• More lines can be added if appropriate

Effect Dialog

• The Descriptions/Conditions/Modifiers line is where you enter your effect. Almost anything can appear here including 'dummy' text. More information on how to create effects in this box is given below.
• The Duration information is specified in time units. Click on the 'RND' word to cycle through the available time unit intervals (RND = Round, MIN = Minute, HR = hour and DAY = day). If the effect should never expire, enter a zero value or leave blank. Otherwise, enter a number to indicate how long until the effect expires using the selected time units.
• Click on 'Targeting' to select whether the effect should apply to the caster (self) or to targets.
• Click through the 'Expend?' options. This determines whether the effect can expire based on usage (i.e. expended), in addition to duration. The options are as follows:
  • Never: The effect will never be expended, and the length of the effect is only governed by the duration.
  • On Next Action: The effect will be expended on the next relevant action. So if the effect is a damage effect then it will be used up when the player next rolls for damage.
  • On Next Roll: The effect will be expended immediately on the next relevant roll made by the character. For example if the effect modifies both attack and damage the effect will be used up on the next attack or damage roll. If there are several targets then each of the targets will be affected by the roll not just the first.
  • Once per modifier: The effect will continue until a roll has been made involving all of the modifiers in the effect. For example if there is an effect which applies to both attack and damage. The attack part will only be used on the first attack even if the character makes several subsequent attacks. The effect will then be expended completely once a damage roll has been made.

Case Study - ATK

So let’s take a look at just one of the possible modifiers that you can use to create effects the ATK modifier.As its name suggests this modifies a character’s attack roll. Normally an attack is made by rolling a d20 but a variety of situations and spells can add or subtract from the number rolled.

Let’s start with a simple example, where the character has a spell cast on him which gives him a +1 to hit. This effect is written ‘ATK: 1’ (without the quotes). In longhand this is telling Fantasy Grounds to add 1 to the d20 dice roll when a player rolls to attack. The value after the modifier ATK can be a number or a dice value and either can be positive or negative. So we could have all of the following ATK: -1d6, ATK: 4, ATK: -2, ATK: 1d4. The format as you can see is always the modifier (ATK) followed by a colon ‘:’ followed by the value ‘1d4’.

We can also specify a player’s attribute bonus as the value for the modifier. The format for this is ‘ATK: [XXX]’, where XXX represents STR, DEX, CON, INT, WIS or CHA. ‘ATK: [WIS]’ will add the players Wisdom modifier (whether positive or negative) to the attack roll. We can also use the negative form ‘ATK: [-WIS]’ to reduce the roll by a specific ability modifier. We can even modify the attribute by halving or doubling it; ‘ATK: [HWIS]’ will add half the wisdom modifier to the roll and ‘ATK: [2WIS] will add double the wisdom modifier. Note that square brackets '[]' are used around the ability modifier. In addition to ability modifiers the character's level [LVL] or proficiency [PRF] or class level [BARBARIAN] can be used as a modifier.

In the case of ATK: 1d4 this will add a 1d4 to any attack roll that the player makes. However we can restrict this to just certain attacks by including a descriptor to the effect. Let’s say that we can only get a bonus on melee attacks; in that case our effect is written ‘ATK: 1d4, melee’. The descriptor is added after the value and separated by a comma ‘,’. Now when used on a character only melee attacks will benefit from the additional dice. If we substitute ‘ranged’ for ‘melee’ then only ranged attacks will get the benefit.

We can go even further and limit the benefit to only opportunity attacks. The format for this is ‘ATK: 1d4, opportunity’. Now FG needs to know when you are making an opportunity attack so when you make the attack hold down shift as you do so. If the player has the effect on him then he will get the bonus to the throw but otherwise nothing happens.

The following are all examples of effects which can be created using the ATK modifier

• ATK: 1d4 - Will apply a 1d4 bonus to the attack roll.
• ATK: [-STR] - Will apply a negative equal to strength modifier to the attack
• ATK: [HLVL], melee, opportunity - will apply half the character's level only to melee opportunity attacks.
• ATK: 1d6, ranged - will apply a 1d6 bonus to only ranged attacks
• ATK: [2CON], melee - will apply twice the CON modifier to any melee attack.
• ATK: [CLERIC] - will add the character's cleric level (only) to the attack. This is useful for multiclassed characters where the bonus relies on the class level rather than the overall level.

Combat Tracker

When an effect is applied to an actor in the combat tracker, some additional fields are available to the DM. See the 5E Combat Tracker for more details.

• Active State: By default, an effect is set to always be active (i.e. On). The active state can be toggled to Skip or Off. If set to Skip, the next application of the effect will be skipped, and then the effect will be set to On again. If set to Off, the effect will no longer be applied to rolls, but will remain in the CT.
• Duration: When the main duration field is set to Start/End Turn values, an additional field will be shown to track the initiative number when the duration should start/end.
• Applied By: The active actor will be used as the source actor of an effect, and shown in the lower right of the effect entry. If no actor is active, then this field is hidden. To set the source actor of an effect, drag the name field of a CT actor onto the label field of a CT effect entry. The source is usually just informational, but may occasionally be used to support advanced effects (such as Marked). Click on the Applied By field to clear the source actor.
• Targets: By default, effects are applied to relevant rolls for all targets. However, some effect components can be targeted (such as attack and damage modifiers). A targeting button is shown next to each effect entry, and can be dragged onto a CT entry or CT-linked token to specify that the effect is targeted to a specific actor or set of actors. Additional options to target all allies or enemies are available by right-clicking on the targeting button. The Targets field is hidden unless targets are defined. Click on the Targets field to clear the targets.

Effect Targeting

As described above in the dialog for Spell/Ability Effect there is a box for ‘Targeting’ which can be set either to ‘Targets’ or ‘Self’. It is important to understand that this isn’t asking you to tell Fantasy Grounds who the target of the effect is but rather where the effect should reside.

If we take a simple case of a character that has set up an effect to deal some extra damage, DMG: 1d6. It is the character who is the beneficiary of this additional damage (not the creature who is going to take it) and so when creating the effect the character needs to set the ‘Targeting’ box in the dialog to read ‘Self’. When the player clicks the action button to apply the effect it will correctly be set on the character even if he has a number of enemies targeted on the Combat Tracker (or none at all).

On the other hand suppose we have some spell or ability which means that an enemy gets disadvantage on attack rolls DISATK:. Clearly there’s no use this effect sitting on the character; it must be placed on an enemy and so when setting the targeting we make sure that it reads ‘Targets’.

So when setting the ‘Targeting’ to ‘Targets’ or ‘Self’ we need to think about what the effect is setting out to achieve, who should benefit or who should take the penalty. Once you have sorted that out you should be able to work out on which creature that effect should be sitting.

There is another layer of depth however to the effect system built into Fantasy Grounds – effect targeting. This concept is probably best illustrated with another example and we’ll use the wizard cantrip True Strike. This spell tells us that on your next turn you gain advantage on your first attack against the target of the spell. Let’s say our spellcaster is up against 6 Goblins and he is going to cast the spell on Goblin 3.

Based on the above we need to figure out who is going to benefit from this spell and clearly it is the caster and so the ‘Targeting’ of the effect needs to be set to ‘Self’. So we set up an effect ADVATK: and set the targeting to ‘Self’. We click on the action button and it places the effect on the Wizard. However there’s a problem because we have just given our Wizard advantage on every attack roll he makes against any Goblin, not just Goblin 3.

What we need to do then is target this effect only at Goblin 3 and we do this by holding down SHIFT and dragging the effect onto Goblin 3. You will see that when you do so the effect appears on the Wizard (because we set the targeting to Self) not on Goblin 3. Now our Wizard will only get advantage on an attack against Goblin 3.

A similar kind of situation arises with the Hex spell which allows the caster to get an additional 1d6 necrotic damage against whomever the spell is cast upon. We create the effect DMG: 1d6 necrotic; and set the targeting to ‘Self’. When cast shift-drag the effect onto the target. Now, only against that target will the caster get the additional damage.

It needs to be noted that not every modifier can be used in this way. Modifiers which can be make use of effect targeting have a ‘T’ in the ‘Notes’ column in the tables below. For convenience these are ATK, AC, DMG, Invisible, RESIST, VULN, IMMUNE, COVER, SCOVER, ADVATK, DISATK, GRANTADVATK, GRANTDISATK.

A Word on Syntax

As has been seen from the notes above there is a syntax which must be followed so that effects will work successfully.

• Modifiers need to be followed by a colon ':' if you intend to have anything after them such as a number, dice etc. If the colon is missed then Fantasy Grounds assumes that there is nothing to follow. Thus if the effect requires nothing after the modifier the colon can be missed out.
• Some modifiers can accept descriptors. These must follow the dice or number separated by a comma. For example ATK: 1d6, melee
• If the modifier is to be modified by a player stat then that should be enclosed in square brackets '[]'. For example SAVE: [CHA]
• Effects can be chained together but each must be separated by a semi colon ';'. For example AC: 1; ATK: 1; DMG: 1d6
• You can add a description to an effect ending in a semi colon. For example Bless; SAVE: 1d4; ATK: 1d4. this is useful for reminding players what the effect is.
• A special tag '!' can be used as a kind of logical NOT. For example the effect 'RESIST: bludgeoning, piercing, !magic' creates an effect which allows whoever has the effect to resist damage from bludgeoning or piercing weapons provided they are not magical. If they are magical then all of the damage will get through. Other useful delimiters are !silver and !adamantine.

Spells and Constitution Saving Throws

In many cases when a Spellcaster casts a spell they must maintain concentration on that spell for the duration. If, whilst concentrating on a spell, the spellcaster takes damage they must make a Constitution saving throw with a DC of 10 or half the damage whichever is greater. On a failure concentration on the spell is lost. Fantasy Grounds can handle this automatically provided that the effect is affixed with ;(C). If the caster who is concentrating on the spell takes damage Fantasy Grounds will make the appropriate saving throw and on a failure remove any effects from any actors who are being influenced by the spell.

So, for example, if an effect is created for the Bless spell then it should be ATK: 1;SAVE: 1;(C)

Note: As noted in the table below 'concentration' can replace the ability modifier for advantage and disadvantage to saving throws or to the save effect itself.

Reference

The following sections details the conditions, modifiers and other components which can be used to create effects within the 5e ruleset. A number of examples are also provide to help users get started.

Conditions

• The following are the conditions from Appendix A of the Player's Handbook which Fantasy Grounds can handle. These are built into the code and can be applied to a character or NPC either via an effect from the character sheet or Combat Tracker or by applying it from the effects button in the UI.
• Not case-sensitive.
• Effects do not stack. So, for example, if a character suffers from Blinded and Frightened they will not suffer a double disadvantage to attack rolls.

(T) = Effects can be targeted to only apply to conditions against certain opponents

Modifiers

• Format: [tag]: [dice/number] [descriptors]
• Case-sensitive
• If colon missing, assume no dice, numerical modifier or descriptors.
• Modifiers stack as long as their bonus type is blank or unique. If two modifiers have the same bonus type, only the larger value will be used.
• When applying effects from PC sheet powers, bracketed ability tags ([STR],[DEX],...) can be added to the modifier dice and numerical portion to adjust by current PC attribute modifiers. The ability tags can be set to negative ([-INT]), half ([HWIS]) or double ([2CHA]). Two additional tags for level ([LVL]) and proficiency bonus ([PRF]) are also supported. Character Classes can also be used and will evaluate to the level for that character in that class. The full name of the class all in capital letters is needed eg. [BARBARIAN], [CLERIC], [WIZARD] etc.

(D) = Dice and numbers supported for value attribute
(N) = Only numbers supported for value attribute
(-) = Neither number nor dice supported for value attribute
(T) = Effects can be targeted to only apply to modifiers against certain opponents

[range] = melee, ranged
[damage type] = acid, cold, fire, force, lightning, necrotic, poison, psychic, radiant, thunder, adamantine, bludgeoning, cold-forged iron, magic, piercing, silver, slashing
[stat] = strength, constitution, dexterity, intelligence, wisdom, charisma
[ability] = strength, constitution, dexterity, intelligence, wisdom, charisma
[skill] = any skill name
[condition] = Any condition as noted above except exhaustion. Note [condition] must be all lower case
* = Multiple entries of this descriptor type allowed.

Special Components

• Unique format for each tag
• Case-sensitive

A Note on IF and IFT

What both these functions do is test a condition and if it is found to be true then the next part of the statement will be carried out, otherwise it will be ignored.

Let’s take the example IF: invisible; DISSAV strength. What this is saying is that if the character on which this effect is placed is invisible then they will have disadvantage on strength saving throws otherwise nothing happens.

The difference between the two components is that IF looks at the source (i.e. the creature on which the effect is sitting) whilst IFT looks at the target of the creature on which the effect is sitting.

Not only can IF and IFT test conditions (such as poisoned, grappled, invisible, etc.) but they can also test for conditional operators. There are five of these ALIGN, SIZE, TYPE, Wounded and Bloodied. As their name suggests, the first three operators test for the alignment, size and type of a creature. Wounded tests to see if the character has any wounds and Bloodied will return true if the target has wounds greater or equal to half of their maximum hit points.

Taken together the testing components and the conditions which they can test for mean that extremely powerful effects can be set up and these are particularly apposite to magic item creation and use. Some #Examples below.

Conditional Operators

• Not case-sensitive

[alignment] = LG, LN, LE, NG, NE, CG, CN, CE, lawful, lawful good, lawful neutral, lawful evil, neutral good, neutral evil, chaotic, chaotic good, chaotic neutral, chaotic evil, good, evil
[size] = T, S, M, L, H, G, tiny, small, medium, large, huge, gargantuan
[creature type] = aberration, beast, celestial, construct, dragon, elemental, fey, fiend, giant, humanoid, monstrosity, ooze, plant, undead, aarakocra, bullywug, demon, devil, dragonborn, dwarf, elf, gith, gnoll, gnome, goblinoid, grimlock, halfling, human, kenku, kuo-toa, kobold, lizardfolk, living construct, merfolk, orc, quaggoth, sahuagin, shapechanger, thri-kreen, titan, troglodyte, yuan-ti, yugoloth
* = Multiple entries of this descriptor type allowed.

The Division Difference Dmg To Target Out Of Cover Rangers

PC Specific Notes

When applying effects from the Actions tab of the PC sheet, special tags can be inserted to provide numerical bonuses based on the PC's current attributes.

Examples

General Examples

• ATK: 2
• SAVE: 1
• DMGO: 2d6
• DMG: 1d6 cold
• RESIST: fire; RESIST: cold
• RESIST: 3 slashing, bludgeoning, piercing, !magic

PC Tag Examples

• ATK: [-DEX]
• DMG: 2d6+1 [CON]

IF and IFT Examples

Specific PC Ability/Trait Examples

• If the Duration, Target, and Expend are not called out, then the default is:
  • Duration=0 (Zero indicates effect should not expire.)
  • Targeting=Targets
  • Expend=Never

Specific Magic Item Examples

Automating Effects on NPCs

FG latches on to certain key words and phrases in traits and actions and creates effect from those words which then appear on the Combat Tracker. For users wishing to create their own NPCs the following contains guidance on how to create these effects.

Weapon Attacks

• Basic Melee Weapon Name. Melee Weapon Attack: +x to Hit [reach 5ft., one target]. Hit: x (ndn + x) <type> damage.
• Basic Ranged Weapon Name. Ranged Weapon Attack: +x to hit, [range n/n ft., one target]. Hit: x (ndn +x) <type> damage
• Two handed option Weapon Name. Melee Weapon Attack: +x to Hit [reach 5ft., one target]. Hit: x (ndn + x) <type> damage or x (ndn) <type> damage if used with two hands.
• Melee or Ranged Melee Weapon Attack: +x to Hit [reach 5ft., one target]. Hit: x (ndn + x) <type> damage or Ranged Weapon Attack: +x to hit, [range n/n ft., one target]. Hit: x (ndn +x) <type> damage
• Multiple damage types Hit: x (ndn+x) <type> damage plus x (ndn+x) <type> damage
• Other Damage Types Hit: x (ndn+x) <type>, <magic>, <adamantine>, <silver>, <cold-forged damage> damage

NOTE: More than one type of damage can be specified separated by a comma

Saving Throws

• Basic Save The target must make a DC x <ability> saving throw.
• Save for half damage The target must make a DC x <ability> saving throw, taking x (ndn+x) <type> damage on a failed save, or half as much damage on a successful one.
• Save against only one damage type Hit: x (ndn+x) <type> damage and the target must make a DC x <ability> saving throw taking x (ndn+x) <type> damage on a failure and half as much damage on a success one

Conditions

The parser will recognise all of the standard conditions listed in the PHB at appendix A except for exhaustion.

• Basic Condition effect the target is <condition>
• Prone condition the target is knocked prone
• Save vs condition The target must make a DC x <ability> saving throw, and on a failure the target is <condition>
• Multiple conditions The target is <condition> and <condition>
• Duration the target is <condition> until <the end of your next turn> / <for x rounds> / <for x minutes>

Damage

• Basic Damage The <NPC> takes x (ndn) <type> damage or The <NPC> takes x <type> damage
• Extra Damage The <NPC> does an extra x (ndn) <type> damage
• Ongoing Damage Hit: x(ndn+x) <type> damage and the target takes x(ndn+x) <type> damage at the start of each of its turns
• Improved Critical Adding a trait named 'Improved Critical' to an NPC will allow them to make a critical roll on a 19-20
• Superior Critical Adding a trait named 'Superior Critical' will allow an NPC to make a critical roll on an 18-20

Immunities and Resistances

These are handled by filling in the appropriate boxes in the NPC sheet. Each damage type should be entered in lower case and if more than one separated by a comma. If the resistance or immunity can be overcome by certain weapon types or by magical weapons then there is wording which can be used to create the proper effect on the CT.

• Magic Weapons [Damage Resistances/Immunities] bludgeoning, slashing and piercing from nonmagical weapons
• Magic and Other Types [Damage Resistances/Immunities] bludgeoning, slashing and piercing from nonmagical weapons that aren’t silvered
• Other Types [Damage Resistances/Immunities] piercing from weapon attacks that aren’t adamantine

Note: Acceptable types are magic/adamantine/silvered/cold-forged

Healing

• Basic Heal The <creature name> regains ndn hit points or The <creature name> regains x hit points.
• Regeneration The <creature name> regains x hit points at the start of its turn if it has at least 1 hit point.
• Regeneration with prevention The <creature name> regains x hit points at the start of its turn if it has at least 1 hit point. If the <creature name> takes <type> damage, this trait doesn't function at the start of the creature’s next turn
• Regeneration with multiple prevention The <creature name> regains x hit points at the start of its turn if it has at least 1 hit point. If the <creature name> takes <type> or <type> damage, this trait doesn't function at the start of the creature’s next turn.
• Death only on zero hit points The <creature name> regains x hit points at the start of its turn. (If the <creature name> takes <type> damage, this trait doesn't function at the start of the creature’s next turn). The <creature name> dies only if it starts its turn with 0 hit points and doesn't regenerate.

Spellcasting

If the NPC can cast spells then you can automate the population of the actual spells into the NPC sheet. Additionally with the correct wording Fantasy Grounds will work out the attacks and spell save DCs where those are present in the spell. The trait for Spellcasting and Innate Spellcasting are given below.

The Division Difference Dmg To Target Out Of Cover Range Chart

Spellcasting

The [NPC] is a nth-level spellcaster. Its spellcasting ability is [ability]. The [NPC] has the following spells prepared.

Cantrips (at will): <spell name>,<spell name>

1st level (4 slots): <spell name>, <spell name>

2nd level (2 slots): <spell name>, <spell name>

Note: It is important that the wording is exactly as above including the punctuation. All spell names should be in lower case separated by a comma.

Innate Spellcasting

The <NPC>'s spellcasting ability is <ability>. It can innately cast the following spells, requiring no material components:

At will: <spell name>, <spell name>

x/Day each: <spell name>, <spell name>

x/Day each: <spell name>, <spell name>

• Overriding automatic calculations If you want to override the automatic calculation of spell save DC's and attacks insert the following into the first line of the trait.

Spellcasting

The [NPC] is a nth-level spellcaster. Its spellcasting ability is [ability] (+x to hit with spell attacks, Spell save DC x). The [NPC] has the following spells prepared.

Innate Spellcasting

The <NPC>'s spellcasting ability is <ability> (Spell save DC x). It can innately cast the following spells, requiring no material components:

The Division Difference Dmg To Target Out Of Cover Ranges

Other Traits

• Magic resistance Include a trait called 'Magic Resistance'. The NPC will then automatically rolled saves vs spells with advantage
• Magic Weapons Include a trait called 'Magic Weapons'. All damage done by the creature will automatically add the magic tag to the damage dealt
• Recharge Where a trait rolls a dice after it is used to see if it can be used again include in the trait heading <Heading> (Recharge x). A six sided dice will automatically be rolled at the start of the creatures turn and if the result equals or exceeds 'x' then the trait will be available again.
• Gnome Cunning When this trait is present the actor will have advantage on all Intelligence, Wisdom and Charisma saving throws against magic.
• Damage Threshold If this trait is present and a number is specified in the text of the trait then a DT:x effect will be created using that number. The creature or object will be immune to any damage from a single attack that is less than x. Damage equal to or above the number specified will be applied normally.

The Division Difference Dmg To Target Out Of Cover Ranger