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Statistics in regulatory science / by Shein-Chung Chow.

By: Chow, Shein-Chung, 1955- [author.].
Material type: materialTypeLabelBookSeries: CRC biostatistics series.Publisher: Boca Raton : CRC Press, [2018]Description: 1 online resource.Content type: text Media type: computer Carrier type: online resourceISBN: 9780429275067; 0429275064; 9781000710816; 1000710815; 9781000710038; 1000710033.Subject(s): Drugs -- Testing | Clinical trials -- Statistical methods | Pharmacy -- Research | Research -- Statistical methods | MATHEMATICS / Probability & Statistics / General | MEDICAL / Pharmacology | REFERENCE / GeneralDDC classification: 615.1072/4 Online resources: Taylor & Francis | OCLC metadata license agreement
Contents:
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.
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 issues that have been commonly misused in the subject area of regulatory science"-- Provided by publisher.
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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.

"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"-- Provided by publisher.

OCLC-licensed vendor bibliographic record.

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