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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)
General Requirements for ANDA Submissions for Generic Products......159
159
Postapproval Changes....160
160
Site Transfer........160
160
Compliance Issues......162
162
Drug Substance (API) Stability.....162
162
Drug Product Stability...162
162
CGMP Considerations...163
163
Formulation Proportionality......199
199
Biopharmaceutics Classification System...........200
200
In Vitro/In Vivo Correlations........201
201
Limitations of In Vitro Dissolution.........201
201
Future Direction......202
202
Filing Review of ANDA........209
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Coordination of the Generic Drug Review Process........210
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Bioequivalence Review Process........211
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Chemistry Review Process.....213
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Labeling Review Process.......214
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Putting It All Together.......215
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Appendix 9.A ANDA Review Process..........216
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Introduction......220
220
Objectives of Bioequivalence Studies.......220
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History of Bioequivalence Evaluation in the United States.........221
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Drug Efficacy Study Implementation (DESI)........221
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Development of the FDA’s Bioavailability/Bioequivalence Regulations...........222
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Creation of an Office of Technology Assessment (OTA)........222
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Publication of the 1977 Bioavailability and Bioequivalence Regulations.........223
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Availability of the Paper NDA Route for Duplicate Drug Products.........223
223