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