权威医学用药书籍速查系统

2. ELEMENTS OF PHARMACEUTICAL DEVELOPMENT

The section that follows elaborates on possible approaches to gaining a more systematic , enhanced understanding of the product and process under development .The examples given are purely illustrative and are not intended to create new regulatory requirements .Through a combination of design o experiments , mathematical models , or studies that lead to mechanistic understanding ) to achieve a higher level of process understanding .

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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:381-383
版本:1
出版时间:2011-01-01
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