Statistics in 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"--

Gespeichert in:
Bibliographische Detailangaben
1. Verfasser: Chow, Shein-Chung 1955- (VerfasserIn)
Format: Elektronisch E-Book
Sprache:English
Veröffentlicht: Boca Raton CRC Press [2018]
Schriftenreihe:CRC biostatistics series
Schlagworte:
Online-Zugang:URL des Erstveröffentlichers
Zusammenfassung:"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"--
Beschreibung: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
Beschreibung:1 online resource
ISBN:9780429275067
0429275064
9781000710816
1000710815
9781000710038
1000710033
DOI:10.4324/9780429275067

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