Clinical trials : study design, endpoints and biomarkers, drug safety, and FDA and ICH guidelines /

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Clinical Trials, Second Edition, offers those engaged in clinical trial design a valuable and practical guide. This book takes an integrated approach to incorporate biomedical science, laboratory data of human study, endpoint specification, legal and regulatory aspects and much more with the fundame...

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Detalles Bibliográficos
Clasificación:Libro Electrónico
Autor principal: Brody, Tom (Autor)
Formato: Electrónico eBook
Idioma:Inglés
Publicado: London : Academic Press is an imprint of Elsevier, 2016.
Edición:Second edition.
Temas:
Clinical trials > Design.
Clinical Trials as Topic
Drug Approval
Research Design
Clinical Trials Data Monitoring Committees
Acceso en línea:Texto completo
Tabla de Contenidos:
  • 1. Origins of drugs
  • 2. Clinical trial design
  • 3. Run-in period
  • 4. Inclusion/exclusion criteria, stratification, and subgroups
  • part I
  • 5. Inclusion/exclusion criteria, stratification, and subgroups
  • part II
  • 6. Blinding, randomization, and allocation
  • 7. Placebo arm as part of clinical trial design
  • 8. Intent-to-treat analysis versus per protocol analysis
  • 9. Biostatistics
  • part I
  • 10. Biostatistics
  • part II
  • 11. Introduction to endpoints
  • 12. Oncology endpoint
  • objective response
  • 13. Oncology endpoints : overall survival and progression-free survival
  • 14. Oncology endpoints : time to progression
  • 15. Oncology endpoint : disease-free survival
  • 16. Oncology endpoint : time to distant metastasis
  • 17. Neoadjuvant therapy versus adjuvant therapy
  • 18. Hematological cancers
  • 19. Biomarkers
  • 20. Endpoints for immune diseases
  • 21. Endpoints for infections
  • 22. Health-related quality of life tools
  • oncology
  • 23. Health-related quality-of-life tools
  • immune disorders
  • 24. Health-related quality-of-life tools
  • infections
  • 25. Drug safety
  • 26. Mechanism of action of diseases and drugs
  • part I
  • 27. Mechanism of action
  • part II (cancer)
  • 28. Mechanism of action
  • part III (immune disorders)
  • 29. Mechanisms of action
  • part IV (infections)
  • 30. Consent forms
  • 31. Package inserts
  • 32. Warning letters
  • 33. Regulatory approval
  • 34. Patents.

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