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GUIDANCE DOCUMENT

Population Pharmacokinetics July 2019

Draft Level 1 Guidance

Not for implementation. Contains non-binding recommendations.

This guidance is being distributed for comment purposes only.

Docket Number:
2019-14856
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research
Center for Biologics Evaluation and Research

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) (Marshall et al. 2015; Lee et al. 2011; Bhattaram et al. 2005). 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).


Submit Comments

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: 2019-14856 .