Description
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.
Scope & Applicability
Product Classes
3influence of pregnancy on the PK of drugs or biologic products
Products for which batch/lot information is particularly important
Example of therapy where dose modification may be needed during pregnancy
Stakeholders
5Assist sponsors in the nonclinical evaluation
Responsible for qualifications, training, and trial conduct; Individual responsible for trial conduct and data governance at a site.; May delegate tasks but retains overall responsibility; Person responsible for the conduct of the clinical trial at a trial site; Responsible for trial conduct and participant safety; Responsible for trial conduct, data integrity, and investigational product management.; Individual responsible for trial conduct at a site and informing the institution.; maintaining
Entity responsible for submitting applications under section 524B
recommendations to primary investigators, clinical researchers, and clinical pharmacologists
Governs top dose in clinical studies
Regulatory Context
Attributes
8safety and efficacy of a drug are established for a particular dosage regimen
describing how the dose would be adjusted during pregnancy
weight-based changes in clearance
Standard PK parameter (Cmax)
Standard PK parameter (AUC)
A key parameter of interest in predicting the risk of drug-drug interactions
regulatory threshold for involving children in clinical investigations
situation where a separate PK study should be considered
Identified Hazards
Hazards
1Risk to be minimized in pregnant women volunteering for studies
Related CFR Sections (1)
- 21CFR312.2§ 312.2 Applicability.
(a) Applicability. Except as provided in this section, this part applies to all clinical investigations of products that are subject to section 505 of the Federal Food, Drug, and Cosmetic Act or to the licensing provisions of the Public Health Service Act (58 Stat. 632, as amended ( 42 U.S.C. 201 etRead full regulation →
Related Warning Letters (4)
- 2025-02-11
Clinical Investigator
ISOThrive, Inc.
- 2023-06-27
Unapproved New Drugs/Misbranded
Suprimo Imports
- 2023-03-28
Clinical Investigator (Sponsor)
Tyrone L. McCall, M.D./Cornea Associates of Texas
- 2022-11-21
Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products
11-11-11 Brands
See Also (4)
- FDA Oversight of PET Drug Products -- Questions and Answers (Status: Final)
- Considerations for the Use of Real-World Data and Real-World Evidence To Support Regulatory Decision-Making for Drug and Biological Products: Guidance for Industry (Status: Final)
- Institutional Review Board (IRB) Written Procedures: Guidance for Institutions and IRBs (Status: Final)
- Impact of Certain Provisions of the Revised Common Rule on FDA-Regulated Clinical Investigations: Guidance for Sponsors, Investigators, and Institutional Review Boards (Status: Final)