期刊
CLINICAL INFECTIOUS DISEASES
卷 59, 期 -, 页码 S437-S444出版社
OXFORD UNIV PRESS INC
DOI: 10.1093/cid/ciu709
关键词
pregnancy; drug trials; pharmacokinetics
资金
- Bill & Melinda Gates Foundation
- Division of Microbiology and Infectious Diseases of the National Institute of Allergy and Infectious Diseases, National Institutes of Health
- NATIONAL INSTITUTE OF GENERAL MEDICAL SCIENCES [T32GM066691] Funding Source: NIH RePORTER
Clinical pharmacology studies that describe the pharmacokinetics and pharmacodynamics of drugs in pregnant women are critical for informing on the safe and effective use of drugs during pregnancy. That being said, multiple factors have hindered the ability to study drugs in pregnant patients. These include concerns for maternal and fetal safety, ethical considerations, the difficulty in designing appropriate trials to assess the study objectives, and funding limitations. This document summarizes the recommendations of a panel of experts convened by the Division of Microbiology and Infectious Diseases at the National Institute of Allergy and Infectious Diseases, National Institutes of Health. These experts were charged with reviewing the issues related to the development of preclinical and clinical drug studies in pregnant women and to develop strategies for addressing these issues. These findings may also be utilized in the development of future drug studies involving pregnant women and their fetus/neonate.
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