Pharmacokinetics in Pregnancy — Study Design, Data Analysis, and Impact on Dosing and Labeling

Issue Date: November 1, 2004
Issued by: Center for Drug Evaluation and Research
Topic(s): Clinical – Pharmacology
Status: Draft

Pharmacokinetics in Pregnancy — Study Design, Data Analysis, and Impact on Dosing and Labeling

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.

Download the Guidance Document