Phase 4 Commitment Category
FDA Data Element Number. None.
CDER Data Element Number. C-DRG-00901
Data Element Name. Phase 4 Commitment Category
Description. This standard provides for all Phase 4 study commitment categories. Phase 4 studies are post-marketing studies 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. CDER Supervisory Project Managers.
Relationship. Phase 4 Fullfilment Category.
FDA Specifications. None.
CDER Specifications. Phase 4 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 Phase 4 Commitment Categories shall consist of three digits.
FDA Approved Date. None.
CDER Approved Date. September 12, 1995.
FDA Revised Date.
CDER Revised Date. December 12, 1995; February 13, 1996, October 4, 1996
Data Values.
| NAME | DEFINITION | FDA CODE |
|---|---|---|
| ADE/Toxicity, Specified | A study that focuses upon a specific adverse drug experience or a specific drug toxicity in a defined patient population. | 001 |
| ADE/Toxicity, Surveillance | A study of overall adverse drug experience where no specific adverse drug experience or specific drug toxicity is being investigated in a defined patient population. | 002 |
| Animal Study | Any study where animals instead of humans are used. | 003 |
| Bioavailability | A study to determine the extent to which an active ingredient of a drug dosage form become available at the site of drug action or in a biological medium believed to reflect accessibility to a site of action. | 004 |
| 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 |
| Carcinogencity | A study to determine the propensity of a drug to produce or exacerbate tumors or cancer cells in humans or animals, including the Asix month modified mouse study. | 006 |
| CMC Method Development or Improvement | A study to determine whether a drug or drug product's chemisty, manufacturing, or controls can be alternatively developed or improved upon. | 007 |
| Dissolution | An in vitro study to determine the characteristics of how a drug product dissolves. | 008 |
| Dose-Proportionality | A study designed to establish whether or not proportionate increases in the dose of a drug product are reflected in proportionate increases in pharmacokinetic parameters (i.e., AUC and CMAX). | 009 |
| DrugDrug Comparison | A study to determine the clinical differences (including pharmacodynamic studies) and similarities between drugs. | 010 |
| DrugDrug Interaction | A study to determine interactions between drugs (including pharmacokinetic and pharmacodynamic interactions, as well as cellular interactions). | 011 |
| DrugFood Interaction | A study to determine the interactions between drugs and food (including how the pharmacokinetics of a drug are affected by food). | 012 |
| Efficacy, Dose/Response | A study to determine a drug's efficacy. | 013 |
| Efficacy, LongTerm | A study to determine a drug's efficacy over a longer period of time than had been studied previously. | 014 |
| Efficacy, New Indication | A study to determine a drug's efficacy for an indication other than that for which it is currently approved. | 015 |
| Efficacy, Subpart H | A study to determine a drug's efficacy under Subpart H (21CFR 314.500 - 21CFR 314.560), which has been established in order to accelerate a drug's approval for serious or life-threatening illnesses. | 033 |
| Human Study | Any study where humans instead of animals are used. | 034 |
| Impurity Identification | A study to identify impurities in the drug product. | 016 |
| Literature Search | A survey of the literature to identify applicable books and journal articles. | 017 |
| Mutagenicity | A study to determine whether a drug has the potential or ability to cause a mutation in a gene, tissue, organ, or appendage, usually by conducting microbial, insect, mammalian cell, and whole animal tests. | 018 |
| Other | Any study not included in other categories. | 019 |
| Pharmacokinetics | A study to determine the kinetic mechanisms of exogenous drug absorption, distribution, biotransformation, release, transport, uptake, and elimination as a function of dosage, and extent and rate of metabolic processes. The study may also include measurement of the drug's effect upon the body in relation to the concentration time curve | 020 |
| Reproductive Effects, Pregnancy | A human study designed to captureand evaluate birth outcomes in women exposed to marketed drugs during pregnancy. | 030 |
| Reproductive Effects,Pre-pregnancy | A human study to determine the effect of a drug on reproduction (including, but not necessarily limited to, libido, copulation, ovulation, ovogenesis, and spermatogenesis). | 021 |
| Special Population, Adolscents | A study to determine a drug's effectiveness or safety in humans from 12 years up to 16 years of age. | 028 |
| Special Population, Children | A study to determine a drug's effectiveness or safety in humans from 2 years up to 12 years of age. | 027 |
| Special Population, Elderly | A study to determine a drug's effectiveness or safety in humans 65 years of age or older. | 022 |
| Special Population, Female | A study to determine a drug's effectiveness or safety in humans of the female gender. | 029 |
| Special Population, Infants | A study to determine a drug's effectiveness or safety in humans from one month up to 2 years of age. | 024 |
| Special Population, Male | A study to determine a drug's effectiveness or safety in humans of the male gender. | 031 |
| Special Population, Neonates | A study to determine a drug's effectiveness or safety in humans from birth up to one month of age. | 035 |
| Special Population, Other | A study to determine a drug's effect in humans having a particular characteristic (e.g., G6PD deficiency, AIDS, renal failure) not already defined. | 023 |
| Special Population, Race/ Ethnicity | A study to determine a drug's effectiveness or safety in humans of a particular race or ethnicity. | 032 |
| Stability | A study over time to determine the propensity of a drug to undergo a chemical or physical change. | 025 |
| Teratogenicity | A study to determine whether a drug can cause physical defects in a developing embryo. | 026 |