FDA's drug review process and the package label : strategies for writing successful FDA submissions /

FDA's Drug Review Process and the Package Label provides guidance to pharmaceutical companies for writing FDA-submissions, such as the NDA, BLA, Clinical Study Reports, and Investigator's Brochures. The book provides guidance to medical writers for drafting FDA-submissions in a way more li...

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Detalles Bibliográficos
Clasificación:Libro Electrónico
Autor principal: Brody, Tom (Autor)
Formato: Electrónico eBook
Idioma:Inglés
Publicado: Cambridge, MA : Academic Press, 2017.
Temas:
United States. > Food and Drug Administration.
Drug approval > Safety regulations > United States.
Drug Approval > legislation & jurisprudence
Drug Approval > organization & administration
M�edicaments > Autorisation de mise sur le march�e > S�ecurit�e > R�eglements > �Etats-Unis.
BUSINESS & ECONOMICS > Infrastructure.
SOCIAL SCIENCE > General.
United States.
Electronic books.
Internet Resources.
Charts.
Acceso en línea:Texto completo
Tabla de Contenidos:
  • 1. Introduction; 2. FDA's decision-making process when assessing ambiguous data; 3. Food effect studies; 4. Dose modification and dose titration; 5. Contraindications; 6. Animal studies; 7. 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 reactions; 10. Drug class analysis; 11. Relatedness; 12. Adjudication of clinical data; 13. Coding; 14. Pooling

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