Statistics in regulatory science

Type Book

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"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"--

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Title Statements

Full title :Statistics in regulatory science / by Shein-Chung Chow.

Summary

Edition Statements

Publication Date:2018

Publication Statements

Publisher(s):CRC Press
Place of Publication:Boca Raton
Language:eng
Publication Date:2018

The Physical Object

Description:1 online resource.

Edition Identifiers

ISBN:9780429275067, 0429275064, 9781000710816, 1000710815, 9781000710038, 1000710033
oclc:on1257751724
LC Classification:RM301.27
Dewey Decimal:615.1072/4

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.

Subjects

Clinical trials -- Statistical methods Clinical Trials as Topic Drugs -- Testing Études cliniques -- Méthodes statistiqu… MATHEMATICS / Probability & Statistics … MEDICAL -- Pharmacology Médicaments -- Essais cliniques Pharmacy -- Research Recherche -- Méthodes statistiques REFERENCE -- General Research -- Statistical methods