权威医学用药书籍速查系统

2 . 4 Design Space

And also help identify the variables and their ranges within which consistent quality can be achieved .A description should be provided in the application of the process parameters and material attributes considered for the design space , those that were included , and their effect on product quality .Process parameters and material attributes that were not varied through development should be highlighted .However , determining the edge of failure or demonstrating failure modes are not essential parts of establishing a design space .

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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 > 2. ELEMENTS OF PHARMACEUTICAL DEVELOPMENT
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:383-386
版本:1
出版时间:2011-01-01
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