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U.S. Department of Health and Human Services

Drugs

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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