02460oam 22005652 450 991086108100332120240513010317.01-000-71081-51-000-71003-30-429-27506-4(CKB)4100000009930727(MiAaPQ)EBC5981919(OCoLC)1130379655(OCoLC-P)1130379655(FlBoTFG)9780429275067(MiAaPQ)EBC31202573(Au-PeEL)EBL31202573(EXLCZ)99410000000993072720191123d2018 uy 0engur|||||||||||txtrdacontentcrdamediacrrdacarrierStatistics in regulatory science /by Shein-Chung Chow1st ed.Boca Raton :CRC Press,[2018]1 online resource (553 pages)Chapman and Hall/CRC Biostatistics Series0-367-22476-3 Includes bibliographical references and index.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"--Provided by publisher.Chapman & Hall/CRC biostatistics series.DrugsTestingClinical trialsStatistical methodsPharmacyResearchResearchStatistical methodsDrugsTesting.Clinical trialsStatistical methods.PharmacyResearch.ResearchStatistical methods.615.19Chow Shein-Chung1955-254512OCoLC-POCoLC-PBOOK9910861081003321Statistics in regulatory science4167033UNINA