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2004 Guidance for Industry Pharmacokinetics in Pregnancy — Study Design, Data Analysis, and Impact on Dosing and Labeling.
DRAFT GUIDANCE
This guidance document is being distributed for comment purposes only.
Comments and suggestions regarding this draft document should be submitted within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance. Submit comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number listed in the notice of availability that publishes in the Federal Register.
For questions regarding this draft document contact (CDER) Kathleen Uhl 301-443-5157.
U.S. Department of Health and Human Services
Food and Drug Administration
Center for Drug Evaluation and Research (CDER)
October 2004
Clinical Pharmacology
Additional copies are available from:
Office of Training and Communications
Division of Drug Information, HFD-240
Center for Drug Evaluation and Research
Food and Drug Administration
5600 Fishers Lane
Rockville, MD 20857
(Tel) 301-827-4573
Contains Nonbinding Recommendations
Draft — Not for Implementation
TABLE OF CONTENTS
I. INTRODUCTION.
II. BACKGROUND
III. DECIDING WHETHER TO CONDUCT A PHARMACOKINETIC STUDY IN PREGNANT WOMEN
IV. STUDY DESIGN
A. Longitudinal Design
B. ...
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Administering drugs to pregnant patients requires careful consideration due to potential effects on both the mother and the fetus. Key considerations include assessing teratogenic risks, recognizing pharmacokinetic changes during pregnancy, categorizing drugs based on safety, timing drug administration appropriately, evaluating maternal health, ensuring effective communication, establishing monitoring plans, and consulting specialists when needed. A personalized and informed approach is essential to balance the potential risks and benefits while prioritizing maternal and fetal well-being.
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