European Parliament Library

Statistics in regulatory science, by Shein-Chung Chow

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
Table Of 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
Language
eng
Literary Form
non fiction
Physical Description
1 online resource (553 pages).
Specific Material Designation
remote
Form Of Item
online
Isbn
9781000710816

Library Locations

  • EP Library Strasbourg

    7 Place Adrien Zeller, Allée du Printemps, Strasbourg, F-67070, FR
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  • EP Library Brussels

    60 rue Wiertz, Brussels, B-1047, BE
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  • EP Library Luxembourg

    Rue du Fort Thüngen, Luxembourg, L-1313, LU
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