FDA's Drug Review Process and the Package Label
Strategies for Writing Successful FDA Submissions

Comprehensive guidance for writing FDA-submissions that are persuasive to FDA-reviewers and that enhance drug approval

Tom Brody (Author)

9780128146477

Paperback, published 1 December 2017

670 pages
23.4 x 19 x 4.1 cm, 1.27 kg

Approx.600 pages

1. Introduction2. FDA's decision-making process when assessing ambiguous data3. Food effect studies4. Dose modification and dose titration5. Contraindications6. Animal studies7. Drug-drug interactions -- Part One (small molecule drugs)8. Drug-drug interactions -- Part Two (therapeutic proteins)9. Immunosuppression, drug-induced hypersensitivity reactions, and drug-induced autoimmune reactions10. Drug class analysis11. Relatedness12. Adjudication of clinical data13. Coding14. Pooling

Subject Areas: Biotechnology [TCB], Pharmacology [MMG], Pharmaceutical industries [KNDP]