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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)
Chapter 8 Drug Product Performance: In Vitro.....183
183
Chapter 9 ANDA Regulatory Approval Process.........207
207
Chapter 10 Bioequivalence and Drug Product Assessment: In Vivo.......219
219
Chapter 11 Statistical Considerations for Establishing Bioequivalence.......243
243
Chapter 12 Outsourcing Bioavailability and Bioequivalence Studies to Contract Research Organizations.....265
265
Chapter 13 Postapproval Changes and Postmarketing Reporting of Adverse Drug Experiences......305
305
Chapter 14 The United States Pharmacopeia/National Formulary: Its History, Organization, and Role in Harmonization.....319
319
Chapter 15 Legal and Legislative Hurdles to Generic Drug Development, Approval, and Marketing...333
333
Therapeutic Equivalence and Generic Drug Products......2
2
Pharmaceutical Equivalents and Pharmaceutical Alternatives.......2
2
Therapeutic Equivalence....3
3
Economic Savings.........3
3
Therapeutic Equivalence, Drug Product Quality, and Drug Product Performance.....3
3
Generic Drug Product Development.....4
4
Selection of a Generic Drug Product for Manufacture........5
5
Legislative and Regulatory Issues.........6
6
Generic Drug User Fee Amendments of 2012.......8
8
Generic Drug Approval...........8
8
Approved Drug Products with Therapeutic Equivalence Evaluations(Orange Book)......10
10
Reference Listed Drug.....11
11
Exclusivity.........13
13
What Is the Goal/Reason for Outsourcing?.267
267
Outsourcing Relationship: Vendor versus Partnership............268
268
Terminology........141
141
API Stability..........141
141
Pharmacopeial and Nonpharmacopeial APIs........141
141
Specifications and Test Methods...142
142
FDA and ICH Guidelines..........143
143
Issues for Multisource APIs..........143
143