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进口化学药品说明书的基本要素 被引量:2

Fundamental element of the package insert of imported chemical drug
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出处 《中国临床药理学杂志》 CAS CSCD 北大核心 2005年第4期311-313,共3页 The Chinese Journal of Clinical Pharmacology
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参考文献7

  • 1MHLW. Guidelines for package inserts for prescription drug( Notification no. 606 of the PAB) [ J/OL]. http://www. mhlw. go. jp, 1997 -04 - 25.
  • 2MHLW. Guidelines for package inserts for prescription drug ( Notification no. 59 of the Safety Division, PAB ) [ J/OL ]. http://www. mhlw.go. jp, 1997-04-25.
  • 3MHLW. Guidelines for Precautions for prescription drug ( Notification no. 607 of the PAB) [J/OL]. http://www. mhlu. go. jp, 1997 -04 -25.
  • 4FDA. Guidance for industry: Clinical studies section of labeling for prescription drugs and biologics -content and format [J/OL]. http://www. fda. gov, 2001 -05 -01.
  • 5EMEA. A guideline on summary of product characteristics [ J/OL ].http://www. emea. eu. int, 1999 - 12 - 11.
  • 6EMEA. A guideline on the readability of the label and package leaflet of medicinal products for human use[ J/OL]. http://www. emea. eu. int,1998 -09 -07.
  • 7鲁爽.有关绝经后妇女HRT的一些新近信息[J/OL].http://www.cde.org.cn,2004-03-20.

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