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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)
Preformulation Studies.....97
97
Impact of Excipient Variability on Product Quality.....99
99
Particle Shape, Size, and Surface Area......100
100
Solubility in Water and Granulating Fluid.........100
100
Crystallinity and Polymorphism......100
100
Moisture Sensitivity and Equilibrium Moisture Content (EMC)........101
101
Bulk and Tapped Densities of Major Components......101
101
Flow Parameters.........101
101
Resources for ANDA Submissions......14
14
Guidance Documents for ANDAs.......14
14
Manual of Policies and Procedures......14
14
Freedom of Information...15
15
Additional Resources Regarding Drug Development.....15
15
Drug Master File.....15
15
United States Pharmacopeia.....16
16
International Conference on Harmonisation.......16
16
Biotechnology-Derived Drug Products (Biosimilars)......16
16
Introduction..........19
19
Patent Restrictions and Exclusivity Granted to an NDA Sponsor......21
21
Comparison With Innovator API......21
21
Chemical Structure......22
22
Impurity Profile.....22
22
Specifications.......24
24
Regulatory Oversight of API Manufacturers.......26
26
Bulk Active Chemical, Post-Approval Changes (BACPAC)........26
26