TY  - BOOK
AU  - Chow,Shein-Chung
TI  - Statistics in regulatory science
T2  - CRC biostatistics series
SN  - 9780429275067
AV  - RM301.27 
U1  - 615.1072/4 23
PY  - 2018///]
CY  - Boca Raton
PB  - CRC Press
KW  - Drugs
KW  - Testing
KW  - Clinical trials
KW  - Statistical methods
KW  - Pharmacy
KW  - Research
KW  - MATHEMATICS / Probability & Statistics / General
KW  - bisacsh
KW  - MEDICAL / Pharmacology
KW  - REFERENCE / General
N1  - 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
N2  - "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"--
UR  - https://www.taylorfrancis.com/books/9780429275067
UR  - http://www.oclc.org/content/dam/oclc/forms/terms/vbrl-201703.pdf
ER  -