Statistics in regulatory science / / by Shein-Chung Chow
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| Autore: |
Chow Shein-Chung <1955->
|
| Titolo: |
Statistics in regulatory science / / by Shein-Chung Chow
|
| Pubblicazione: | Boca Raton : , : CRC Press, , [2018] |
| Edizione: | 1st ed. |
| Descrizione fisica: | 1 online resource (553 pages) |
| Disciplina: | 615.19 |
| Soggetto topico: | Drugs - Testing |
| Clinical trials - Statistical methods | |
| Pharmacy - Research | |
| Research - Statistical methods | |
| Nota di bibliografia: | Includes bibliographical references and index. |
| Nota di contenuto: | 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. |
| 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"-- |
| Titolo autorizzato: | Statistics in regulatory science |
| ISBN: | 1-000-71081-5 |
| 1-000-71003-3 | |
| 0-429-27506-4 | |
| Formato: | Materiale a stampa  |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione: | Inglese |
| Record Nr.: | 9910861081003321 |
| Lo trovi qui: | Univ. Federico II |
| Opac: | Controlla la disponibilità qui |
Serie:
Chapman & Hall/CRC biostatistics series.