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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)
Introduction.......184
184
Preferred Provider........269
269
Timing/Cost Considerations........270
270
Identification of Appropriate CROs.......271
271
Assessment of Capabilities and Experience.......271
271
Clinical Capabilities..........271
271
Bioanalytical Capabilities......272
272
Pharmacokinetic Capabilities............272
272
Timeline Assessment.........272
272
CRO Qualification.......272
272
Due Diligence.......272
272
Clinical Site Qualification/Audit.....273
273
Bioanalytical Site Qualification.........274
274
Pharmacokinetic Site Qualification......274
274
Competitive Bids/Defining the Deliverables....275
275
Final Report Content and Format........275
275
Final Written Report.....275
275
Submission of Data and Reports to the FDA.........276
276
Protocol Development..277
277
Protocol Format............277
277
Clinical Study Population........278
278
Inclusion/Exclusion Criteria.......278
278
Laboratory Chemistries/Special Tests/Physicals.......279
279
Dose and Safety Considerations........279
279
Clinical Conduct.......279
279
Clinical Database..........280
280