Pharmacokinetics Guidance for Industry

This draft guidance document is being distributed for comment purposes only.

This guidance is intended to assist sponsors of new drug applications (NDAs) and biologics license applications (BLAs) in the application of population pharmacokinetic (population PK) analysis. Population PK analysis is frequently used to guide drug development and inform recommendations on therapeutic individualization (e.g., through tailored dosing). Adequate population PK data collection and analyses submitted in marketing applications have in some cases alleviated the need for postmarketing requirements (PMRs) or postmarketing commitments (PMCs).

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