权威医学用药书籍速查系统

2. Q4B OUTCOME

The ICH Steering Committee , based on the evaluation by the Q4B Expert Working Group ( EWG ) , recommends that the official pharmacopoeial texts , Ph . Eur . 2.6.1 .Sterility Tests , can be used as interchangeable in the ICH regions subject to the conditions detailed below .Testing conditions for medical devices , such as sutures , are outside the scope of the ICH recommendation .The acceptance criteria are harmonized between the three pharmacopoeias .

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——《2011药品注册的国际技术要求.质量部分》
书名:《2011药品注册的国际技术要求.质量部分》
栏目:2011药品注册的国际技术要求.质量部分 > EVALUATION AND RECOMMENDATION OF PHARMACOPOEIAL TEXTS FOR USE IN THE ICH REGIONS ON STERILITY TEST GENERAL CHAPTER Q4B ANNEX 8(R1) > EVALUATION AND RECOMMENDATION OF PHARMACOPOEIAL TEXTS FOR USE IN THE ICH REGIONS ON STERILITY TEST GENERAL CHAPTER Q4B
作者:美国ICH指导委员会 周海钧
参编:王执,王知坚,匡荣,李洋,张洁
页码:356-357
版本:1
出版时间:2011-01-01
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