权威医学用药书籍速查系统

3. SUBMISSION OF PHARMACEUTICAL DEVELOPMENT AND RELATED INFORMATION IN COMMON TECHNICAL DOC

Pharmaceutical development information is submitted in Section P . 2 of the CTD . Other information resulting from pharmaceutical development studies could be accommodated by the CTD format in a number of different ways and some specific suggestions are provided below .However , the applican should clearly indicate where the different information i located .In addition to what is submitted in the application certain aspects ( e . g . , product lifecycle management , continua improvement ) of this guideline are handled under the applicant ’ s pharmaceutical quality system ( see ICH Q10 ) .

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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:389-391
版本:1
出版时间:2011-01-01
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