药品开发,固体口服剂型第二版 458条(本栏目收费,不能显示细节,电话15274084725)
Method Validation..........144 144
Shelf-Life Development and Assignment.......144 144
Intermediates for Drug Products........145 145
Specifications..........146 146
Holding Time..........146 146
Drug Product Stability........146 146
Pharmacopeial and Nonpharmacopeial Products.....147 147
Specifications and Test Methods...147 147
Method Validation..........148 148
FDA and ICH Guidelines........148 148
Stability Protocol.......149 149
Shelf-Life Development.....150 150
Action Limits........150 150
Expiration Date Assignment.......151 151
Annual Stability.........152 152
Extension of Expiration Dating Period........152 152
Bulk Holding......152 152
Controlled Room Temperature......156 156
Stability of Products Containing Iron........156 156
Reprocessing and Reworking........157 157
Controlled Drugs......158 158
Storage Requirements for CI to CV Drugs.......158 158
Submission Requirements...159 159
ANDA Submission.........159 159