权威医学用药书籍速查系统

2. PHARMACEUTICAL DEVELOPMENT

The aim of pharmaceutical development is to design a quality product and its manufacturing process to consistently deliver the intended performance of the product .The Pharmaceutical Development section should describe the knowledge that establishes that the type of dosage form selected and the formulation proposed are suitable for the intended use .Information to support the safety of excipients , when appropriate , should be cross-referenced ( 3.2 .

……
——《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 I: 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:365-369
版本:1
出版时间:2011-01-01
© 2015-2019 天山医学院 XiaBBY#VIP.QQ.COM