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)
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