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[null,"1.","Record Nr.",null,"UNINA9910861081003321"]
[null,null,"Autore",null,"Chow Shein-Chung <1955->"]
[null,null,"Titolo",null,"Statistics in regulatory science / / by Shein-Chung Chow"]
[null,null,"Pubbl/distr/stampa",null,"Boca Raton : , : CRC Press, , [2018]"]
[null,null,"ISBN",null,"1-000-71081-5"]
[{"$nulls":4},"1-000-71003-3"]
[{"$nulls":4},"0-429-27506-4"]
[null,null,"Edizione",null,"[1st ed.]"]
[null,null,"Descrizione fisica",null,"1 online resource (553 pages)"]
[null,null,"Collana",null,"Chapman and Hall/CRC Biostatistics Series"]
[null,null,"Disciplina",null,"615.19"]
[null,null,"Soggetti",null,"Drugs - Testing"]
[{"$nulls":4},"Clinical trials - Statistical methods"]
[{"$nulls":4},"Pharmacy - Research"]
[{"$nulls":4},"Research - Statistical methods"]
[null,null,"Lingua di pubblicazione",null,"Inglese"]
[null,null,"Formato",null,"Materiale a stampa"]
[null,null,null,"Livello bibliografico","Monografia"]
[null,null,null,"Nota di bibliografia","Includes bibliographical references and index."]
[null,null,"Nota di contenuto",null,"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."]
[null,null,null,"Sommario/riassunto","\"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\"--"]