M

FIGURE 3 NDA review process, http://www.fda.gov/cder.

TABLE 1 General list of Studies Submitted to Support the Clinical Pharmacology and Biopharmaceutics Portion of the NDA

Table of contents present and sufficient to locate reports, tables, data, etc. Tabular listing of all human studies HPK summary Labeling

Reference bioanalytical and analytical methods Bioavailability and bioequivalence studies Mass balance study BA studies Absolute BA Relative BA BE studies Average BE Food-drug interaction

Dissolution tests (In vitro-in vivo comparison studies) Studies using human biomaterials Plasma protein binding studies Blood/plasma ratio

Metabolism studies using hepatocytes, microsomes, etc. Human pharmacokinetics studies PK, and initial safety and tolerability in healthy Volunteers Single dose Multiple dose PK, and initial safety and tolerability in patient Volunteers Single dose Multiple dose Dose proportionality Single dose Multiple dose

PK in population subsets to evaluate effects of intrinsic factors Ethnicity Gender Pediatrics Geriatrics Renal impairment Hepatic impairment PK to evaluate effects of extrinsic factors

Drug-drug interaction: Effects on primary drug Population PK studies Summary table of PK/PD studies PK/PD studies in volunteers PK/PD studies in patients Individual data sets for all PK and PK/PD studies in electronic format Other

Genotype/phenotype studies Chronopharmacokinetics also encouraged to refer to the FDA website and the ICH Common Technical Document that provides information on what information an new drug application should contain.

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