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DATA STANDARDS MANUAL |
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DATA STANDARDS MANUAL |
FDA Data Element Number. None.
CDER Data Element Number. C-DRG-00919
Version Number. 001
Data Element Name. PACT Commitment Category
Description. This standard provides for all PACT study commitment categories. PACT studies are post-marketing studies for the Office of Generic Drug Products that are imposed upon a pharmaceutical firm as a condition for drug approval. Defining the various commitment categories of these studies will permit CDER management to determine trend analysis.
Source. Office of Generic Drug Products.
Relationship. PACT Fullfilment Category.
FDA Specifications. None.
CDER Specifications. PACT Commitment Category shall consist of an alphabetic term which has a maximum length restricted to 60 characters, with the comma and hyphen being the only punctuation permissible. Codes representing these PACT Commitment Categories shall consist of three digits.
FDA Approved Date. None.
CDER Approved Date. January 21, 2000.
FDA Revised Date.
CDER Revised Date.
Data Values.
| NAME | DEFINITION | FDA CODE |
|---|---|---|
| Bioequivalence | A study to determine whether the pharmacokinetics of a drug product is statistically distinguishable from that of another drug product with the same active ingredients. | 005 |
| Dissolution | An in vitro study to determine the characteristics of how a drug product dissolves. | 008 |
| Special Population, Pediatric | A study to determine a drug's effectiveness or safety in humans from birth up to 16 years of age. | 036 |
| Stability | A study over time to determine the propensity of a drug to undergo a chemical or physical change. | 025 |
| Methods validation of sample | A study to determine the analysis of non-compendial products. | 037 |