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)
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