Innovative Statistics in Regulatory Science

ISBN-13: 9780367224769 / Angielski / Twarda / 2019 / 530 str.

Shein-Chung Chow

Opis

"The proposed book will focus on practical issues in pharmaceutical/clinical research and development from both regulatory and scientific perspectives. The book will outline and clarify those issues that have been commonly misused in the subject area of regulatory science"--

Spis treści

1.  Introduction. 2. Totality-of-the-Evidence. 3. Hypotheses Testing Versus Confidence Interval. 4. Endpoint Selection. 5. Non-inferiority Margin. 6. Missing Data. 7. Multiplicity. 8. Sample Size. 9. Reproducible Research. 10. Extrapolation. 11. Consistency Evaluation. 12. Drug Products with Multiple Components. 13. Adaptive Trial Design. 14. Selection Criteria in Adaptive Dose Finding. 15. Generic Drugs and Biosimilars. 16. Precision and Personalized Medicine. 17. Big Data Analytics. 18. Rare Disease Drug Development.