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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)
Technical Partnership Between the API Manufacturer and the Drug Product Manufacturer........27
27
Identifying and Qualifying API Sources.......27
27
Method Development and Its Importance......32
32
Method Development....34
34
API Test Methods.....35
35
In-Process Test Methods......37
37
Finished Dosage Form Test Methods........37
37
Method Validation.....40
40
Objectives of Method Validation.....40
40
Role of Tmax in Bioequivalence Analysis.......228
228
General Bioequivalence Study Design Recommendations......229
229
Number of Subjects; Single-Dose versus Steady-State Bioequivalence Studies.....230
230
Appropriate Drug Product Strength for Bioequivalence Studies.......230
230
Fed Bioequivalence Studies......230
230
Study Population in Bioequivalence Studies........231
231
Types of Evidence to Establish Bioavailability and Bioequivalence.......231
231
Bioequivalence Studies with Pharmacokinetic Endpoints......231
231
Bioequivalence Studies with Pharmacodynamic Endpoints...233
233
Chapter 1 Generic Drug Product Development and Therapeutic Equivalence.....1
1
Chapter 2 Active Pharmaceutical Ingredients....19
19
Chapter 3 Analytical Methods Development and Methods Validation for Oral Solid Dosage Forms....31
31
Chapter 4 Experimental Formulation Development......51
51
Chapter 5 Scale-Up, Technology Transfer, and Process Performance Qualification....95
95
Method Validation Requirements.......40
40
Compendial Analytical Procedures........40
40
Noncompendial Methods.......41
41