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)
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........209 209
Coordination of the Generic Drug Review Process........210 210
Bioequivalence Review Process........211 211
Chemistry Review Process.....213 213
Labeling Review Process.......214 214
Putting It All Together.......215 215
Appendix 9.A ANDA Review Process..........216 216
Introduction......220 220
Objectives of Bioequivalence Studies.......220 220
History of Bioequivalence Evaluation in the United States.........221 221
Drug Efficacy Study Implementation (DESI)........221 221
Development of the FDA’s Bioavailability/Bioequivalence Regulations...........222 222
Creation of an Office of Technology Assessment (OTA)........222 222
Publication of the 1977 Bioavailability and Bioequivalence Regulations.........223 223
Availability of the Paper NDA Route for Duplicate Drug Products.........223 223