权威医学用药书籍速查系统

Appendix 2. Illustrative Examples

A . Use of a risk assessment tool .The team could then rank the variables based on probability , severity , and detectability using failure mode effects analysis ( FMEA ) or similar tools based on prior knowledge and initial experimental data .Operating above the upper limit of the design space can cause excessive impurity formation , while operating below the lower limit o the design space can result in excessive particle attrition .

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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 > PHARMACEUTICAL DEVELOPMENT Q8(R2) > PART II: PHARMACEUTICAL DEVELOPMENT-ANNEX
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:396-401
版本:1
出版时间:2011-01-01
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