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)
1984 Hatch–Waxman Amendments........223 223
1992 Revisions to the FDA’s Bioavailability/Bioequivalence Regulations........224 224
Early Days of the FDA’s Bioequivalence Review Process......224 224
Two One-Sided Tests Procedure for Analyzing Bioequivalence Data.......225 225
Logarithmic Transformation of Bioequivalence Data......225 225
Reference-Scaled Average Bioequivalence Approach........226 226
Use Patents.........55 55
Literature Search......55 55
Regulatory Strategy..........55 55
Sourcing of the Active Raw Material(s).....56 56
Alternate Vendor Sourcing...........58 58
Formulation Development ........59 59
Equipment Selection for Formulation Development.....62 62
Assessment of the Final Formulation and Exhibit-Batch Production........63 63
Development Report........64 64
Master Manufacturing Document...........66 66
Exhibit-Batch Production.....67 67
Quality-by-Design Approaches.......68 68
Appendix 4.A1: Product Development Flow Chart........76 76
Appendix 4.A2: Description of the Formulation Development and Subsequent Exhibit-Batch Manufacture of a Generic Solid Oral Dosage Form (Tablet)............78 78
Acquisition of API and Technical Package Following Comprehensive Literature and Patent Reviews.......78 78
Preformulation Studies on the API.....78 78
Innovator Product Characterization......78 78
Formulation Development.....79 79
Manufacturing Method.....80 80
Range Studies—Investigation of Formulation and Process Variables.....81 81
Formulation Variables.......81 81
Process Variables.........85 85
Similarity and Difference Factors.....87 87