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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13136136841)
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