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
|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|