Activities at FDA : Drug Use in Pregnancy and Lactation

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著者

    • UHL Kathleen
    • U.S. Food and Drug Administration, Office of Women's Health

抄録

Many women experience medical problems during pregnancy and while breast-feeding that require chronic or episodic treatment with prescription medication. Pregnant and lactating women are typically excluded from clinical drug trials. At the time of a drug's initial marketing, there are seldom meaningful human data on the effects of that drug during pregnancy and lactation. Even after years of marketing, data in product labeling regarding use during pregnancy and lactation rarely go beyond the data available at the time of initial marketing.<BR>This paper will describe FDA's approach to pregnant and lactating women including revising regulations for labeling and guidance documents for industry and reviewers pertinent to the collection and interpretation of data in pregnant and lactating women. The consistent application of adequate study designs would improve the data available regarding drug use during pregnancy and lactation. The goal of improved labeling is to provide clinically useful information that aids the health care provider and patient in making decisions about drug use during pregnancy and lactation.

収録刊行物

  • 臨床薬理 = JAPANESE JOURNAL OF CLINICAL PHARMACOLOGY AND THERAPEUTICS  

    臨床薬理 = JAPANESE JOURNAL OF CLINICAL PHARMACOLOGY AND THERAPEUTICS 37(6), 324-330, 2006-11-30 

    The Japanese Society of Clinical Pharmacology and Therapeutics

参考文献:  25件

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各種コード

  • NII論文ID(NAID)
    10018813986
  • NII書誌ID(NCID)
    AN0025404X
  • 本文言語コード
    ENG
  • 資料種別
    REV
  • ISSN
    03881601
  • データ提供元
    CJP書誌  J-STAGE 
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