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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)
Introduction.........96
96
Product Development.........97
97
Bioequivalency..........351
351
Prescription-to-OTC Switches......352
352
505(b)(2) NDAs.....352
352
Patent-Related Issues........355
355
Scope of Hatch–Waxman Patent Listing Provisions......355
355
30-Month Delay of ANDA and 505(b)(2) NDA Final Approval..........357
357
Hatch–Waxman Patent Infringement Litigation........358
358
Declaratory Judgment Actions.........358
358
Bolar-Type Considerations ......359
359
Authorized Generics........360
360
Miscellaneous.........362
362
Withdrawal of Approval of Innovator Drug......362
362
“Moving Target” and Disagreements with the FDA..........363
363
Application Approval Delays.......364
364
Therapeutic Equivalence........365
365
Risk Evaluation and Mitigation Strategies...365
365
Copyrighted Labeling........366
366
Antitrust Considerations.........366
366
Freedom of Information Act.......367
367
Clinical Trials Registry.....367
367
Compliance Issues.......368
368
“Fraud Policy”; cGMP Problems.....369
369