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Statistics in regulatory science
- Author / Creator
- Available as
- Online
- Summary
-
"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 issue...
"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"--
Details
- Creator
- by Shein-Chung Chow
- Format
- Books
- Language
- English
- Publication
-
- 1st ed
- Boca Raton : CRC Press, [2018]
- Physical Details
-
- 1 online resource (553 pages)
- ISBNs
- 9781000710816, 1000710815, 9781000710038, 1000710033, 9780429275067, 0429275064, 0367224763
- OCLC
- on1130379655
- Includes bibliographical references and index.
- Totality-of-the-evidence -- Hypotheses testing versus confidence interval -- Endpoint selection -- Non-inferiority margin -- Missing data -- Multiplicity -- Sample size -- Reproducible research -- Extrapolation -- Consistency evaluation -- Drug products with multiple components -- Adaptive trial design -- Selection criteria in adaptive dose finding -- Generic drugs and biosimilars -- Precision and personalized medicine -- Big data analytics -- Rare disease drug development