Cargando…
Clinical trials : study design, endpoints and biomarkers, drug safety, and FDA and ICH guidelines /
Clinical Trials: Study Design, Endpoints and Biomarkers, Drug Safety, and FDA and ICH Guidelines is a practical guidebook for those engaged in clinical trial design. This book details the organizations and content of clinical trials, including trial design, safety, endpoints, subgroups, HRQoL, conse...
| Clasificación: | Libro Electrónico |
|---|---|
| Autor principal: | |
| Formato: | Electrónico eBook |
| Idioma: | Inglés |
| Publicado: |
London :
Academic,
2012.
|
| Temas: | |
| Acceso en línea: | Texto completo |
Tabla de Contenidos:
- Introduction. Abbreviations and definitions. Biography. 1. The Origins of Drugs 2. Introduction to regulated clinical trials 3. Run-in Period 4. Inclusion/exclusion criteria, stratification, and subgroups, Part I 5. Inclusion and stratification criteria, Part II 6. Randomization, allocation, and blinding 7. Placebo arm as part of clinical study design 8. Intent to treat analysis vs. per protocol analysis 9. Biostatistics 10. Introduction to endpoints for clinical trials in pharmacology 11. Endpoints in clinical trials on solid tumors : objective response 12. Oncology endpoint: overall survival and progression-free survival 13. Oncology endpoint: time to progression 14. Oncology endpoint: disease-free survival 15. Oncology endpoint: time to distant metastasis 16. Neoadjuvant therapy versus adjuvant therapy 17. Hematological cancers 18. Biomarkers and personalized medicine 19. Endpoints in immune diseases 20. Endpoints in clinical trials on infections 21. Health-related quality of life 22. Health-related quality of life instruments for immune disorders 23. Health-related quality of life instruments and Infections 24. Drug safety 25. Mechanism of action, Part I 26. Mechanism of Action, Part II: Cancer 27. Mechanism of Action, Part III: Immune Diseases 28. Mechanism of Action, Part IV: Infections 29. Consent Forms 30. Package Inserts 31. Regulatory Approval 32. Patents. Index.