Chow, Shein-Chung, 1955-
Statistics in regulatory science / by Shein-Chung Chow. - 1 online resource. - CRC biostatistics series .
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"--
9780429275067 0429275064 9781000710816 1000710815 9781000710038 1000710033
Drugs--Testing.
Clinical trials--Statistical methods.
Pharmacy--Research.
Research--Statistical methods.
MATHEMATICS / Probability & Statistics / General
MEDICAL / Pharmacology
REFERENCE / General
RM301.27
615.1072/4
Statistics in regulatory science / by Shein-Chung Chow. - 1 online resource. - CRC biostatistics series .
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"--
9780429275067 0429275064 9781000710816 1000710815 9781000710038 1000710033
Drugs--Testing.
Clinical trials--Statistical methods.
Pharmacy--Research.
Research--Statistical methods.
MATHEMATICS / Probability & Statistics / General
MEDICAL / Pharmacology
REFERENCE / General
RM301.27
615.1072/4