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.
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.
Shein-Chung Chow, Ph.D. is currently a Professor at Duke University School of Medicine, Durham, NC. He was previously the Associate Director at the Office of Biostatistics, Center for Drug Evaluation and Research, United States Food and Drug Administration (FDA). Dr. Chow has also held various positions in the pharmaceutical industry such as Vice President at Millennium, Cambridge, MA, Executive Director at Covance, Princeton, NJ, and Director and Department Head at Bristol-Myers Squibb, Plainsboro, NJ. He was elected Fellow of the American Statistical Association and an elected member of the ISI (International Statistical Institute). Dr. Chow is Editor-in-Chief of the Journal of Biopharmaceutical Statistics and Biostatistics Book Series, Chapman and Hall/CRC Press, Taylor & Francis, New York. Dr. Chow is the author or co-author of over 300 methodology papers and 30 books.
Inhaltsangabe
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.
