This guidance describes a basic framework for designing and conducting PK/PD studies in pregnant women. It provides recommendations to sponsors on how to assess the influence of pregnancy on the pharmacokinetics (PK), and where appropriate, the pharmacodynamics (PD) of drugs or biologic products. Additionally, this guidance provides recommendations to primary investigators, clinical researchers, and clinical pharmacologists about issues to consider when designing and conducting PK studies in pregnant women.
Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All comments should be identified with the title of the guidance.