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FDA Public Meeting Report on "Drug Interactions With Hormonal Contraceptives: Public Health and Drug Development Implications".

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第一作者： Mohammad,Akbar

第一单位： Office of Clinical Pharmacology, Office of Translational Sciences (OTS), Center for Drug Evaluation and Research (CDER), US Food and Drug Administration (FDA), Silver Spring, MD, USA.

作者： Mohammad,Akbar ^[1] ; Erin,Berry-Bibee ^[2] ; Diana L,Blithe ^[3] ; Ruth S,Day ^[4] ; Alison,Edelman ^[5] ; Joachim,Höchel ^[6] ; Roxanne,Jamshidi ^[7] ; Myong-Jin,Kim ^[1] ; Li,Li ^[1] ; Vivek S,Purohit ^[8] ; Jim A,Turpin ^[9] ; Pamela E,Scott ^[10] ; David G,Strauss ^[1] ; Haiying,Sun ^[11] ; Naomi K,Tepper ^[12] ; Lei,Zhang ^[1] ; Chongwoo,Yu ^[1]

作者单位： Office of Clinical Pharmacology, Office of Translational Sciences (OTS), Center for Drug Evaluation and Research (CDER), US Food and Drug Administration (FDA), Silver Spring, MD, USA. ^[1] Department of Obstetrics and Gynecology, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.;Division of Reproductive Health, Centers for Disease Control and Prevention (CDC), Atlanta, GA, USA. ^[2] Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health (NIH), Bethesda, MD, USA. ^[3] Medical Cognition Laboratory, Duke University, Durham, NC, USA. ^[4] Department of Obstetrics and Gynecology, Oregon Health & Science University, Portland, OR, USA. ^[5] Clinical Pharmacology, Bayer AG, Berlin, Germany. ^[6] Department of Obstetrics and Gynecology, George Washington University School of Medicine and Health Sciences, Washington, DC, USA. ^[7] Clinical Pharmacology, Pfizer, New London, CT, USA. ^[8] Prevention Sciences Program, Division of AIDS, National Institute of Allergy and Infectious Diseases, NIH, Rockville, MD, USA. ^[9] Office of Women's Health (OWH), Office of the Commissioner, FDA, Silver Spring, MD, USA. ^[10] Novartis Institutes for Biomedical Research, East Hanover, NJ, USA. ^[11] Division of Reproductive Health, Centers for Disease Control and Prevention (CDC), Atlanta, GA, USA. ^[12]

关键词 drug development drug interaction hormonal contraceptive labeling and communication

主题词避孕药, 女用(Contraceptive Agents, Female);药物相互作用(Drug Interactions);人类(Humans);公共卫生(Public Health);美国(United States);美国食品和药物管理局(United States Food and Drug Administration)

DOI 10.1002/jcph.1285

PMID 30144093

发布时间 2025-05-30

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