Front Cover; Preface; Contents; PART I ADMINISTRATIVE GUIDELINES FOR NEW PRODUCT DEVELOPMENT; 1. Drug Development Teams; 2. FDA Approvable Indications and Other Considerations; 3. Data Presentation for Global Submissions: Text and Tabular Exposition -- CTD Format; 4. Technology Change -- Enabling Clinical Research and Drug Development Processes; 5. Working with a Contract Research Organization (CRO); 6 Industry and FDA Liaison; PART II GLOBAL REGULATORY SUBMISSION OF DRUGS, BIOLOGICS AND DEVICES FOR NEW PRODUCT APPROVAL; 7. Nonclinical Drug Development: Pharmacology, DrugMetabolism, and Toxicology
Summary
The thoroughly revised Fifth Edition of New Drug Approval Process supplies readers with the latest global changes that affect pharmaceutical product approval and influence how new products are researched and marketed
