Quantitative evaluation of safety in drug development : design, analysis and reporting /

State-of-the-Art Methods for Drug Safety AssessmentResponding to the increased scrutiny of drug safety in recent years, Quantitative Evaluation of Safety in Drug Development: Design, Analysis and Reporting explains design, monitoring, analysis, and reporting issues for both clinical trials and obser...

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Detalles Bibliográficos
Clasificación:Libro Electrónico
Otros Autores: Jiang, Qi (Biostatistician) (Editor ), Xi, H. Amy (Editor )
Formato: Electrónico eBook
Idioma:Inglés
Publicado: Boca Raton : Chapman & Hall/CRC, 2014.
Colección:Chapman & Hall/CRC biostatistics series.
Temas:
Drugs > Testing.
Biometry.
Drug development.
Biometry
Médicaments > Essais cliniques.
Biométrie.
Médicaments > Développement.
biometrics.
Drug development
Drugs > Testing
Acceso en línea:Texto completo
Descripción
Sumario:State-of-the-Art Methods for Drug Safety AssessmentResponding to the increased scrutiny of drug safety in recent years, Quantitative Evaluation of Safety in Drug Development: Design, Analysis and Reporting explains design, monitoring, analysis, and reporting issues for both clinical trials and observational studies in biopharmaceutical product development. It presents the latest statistical methods for drug safety assessment. The book's three sections focus on study design, safety monitoring, and data evaluation/analysis. The book addresses key challenges across regulatory agencies, industry,
Descripción Física:1 online resource
Bibliografía:Includes bibliographical references and index.
ISBN:9781466555471
1466555475

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