Quantitative Evaluation of Safety in Drug Development: Design, Analysis and Reporting (Chapman & Hall/CRC Biostatistics Series)

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9781466555457: Quantitative Evaluation of Safety in Drug Development: Design, Analysis and Reporting (Chapman & Hall/CRC Biostatistics Series)

State-of-the-Art Methods for Drug Safety Assessment

Responding 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, and academia. It discusses quantitative approaches to safety evaluation and risk management in drug development, covering Bayesian methods, effective safety graphics, and risk-benefit evaluation.

Written by a team of experienced leaders, this book brings the most advanced knowledge and statistical methods of drug safety to the statistical, clinical, and safety community. It shares best practices and stimulates further research and methodology development in the drug safety area.

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About the Author:

Qi Jiang, PhD, is an executive director of Global Biostatistical Science at Amgen Inc. Dr. Jiang is a fellow of the American Statistical Association, a member of many industry-wide initiatives, and an associate editor of the journal Statistics in Biopharmaceutical Research (SBR). She has over 18 years of clinical trial experience in early and late clinical development phases across a broad spectrum of therapeutic areas. Her research interests include drug safety monitoring and analyses, benefit-risk assessment, clinical meaningfulness, dichotomization, meta-analyses, network meta-analysis, adaptive design, and non-inferiority study design and analyses.

H. Amy Xia, PhD, is an executive director of Global Biostatistical Science at Amgen Inc. Dr. Xia is a member of many industry-wide initiatives. In the past 18 years, she has worked on designing, executing, and reporting clinical trials as well as observational studies for developing pharmaceutical and medical device products in a wide range of different disease areas. Her research interests include safety biostatistics, signal detection, Bayesian design, monitoring and analysis of clinical trials, meta-analysis, and adaptive design.

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Editorial: Taylor Francis Inc, United States (2014)
ISBN 10: 1466555459 ISBN 13: 9781466555457
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Descripción Taylor Francis Inc, United States, 2014. Hardback. Estado de conservación: New. Language: English . Brand New Book. State-of-the-Art Methods for Drug Safety Assessment Responding 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, and academia. It discusses quantitative approaches to safety evaluation and risk management in drug development, covering Bayesian methods, effective safety graphics, and risk-benefit evaluation. Written by a team of experienced leaders, this book brings the most advanced knowledge and statistical methods of drug safety to the statistical, clinical, and safety community. It shares best practices and stimulates further research and methodology development in the drug safety area. Nº de ref. de la librería AA69781466555457

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Descripción Taylor and Francis, 2014. HRD. Estado de conservación: New. New Book. Shipped from US within 10 to 14 business days. Established seller since 2000. Nº de ref. de la librería VT-9781466555457

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Editorial: Taylor Francis Inc, United States (2014)
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Descripción Taylor Francis Inc, United States, 2014. Hardback. Estado de conservación: New. Language: English . Brand New Book. State-of-the-Art Methods for Drug Safety Assessment Responding 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, and academia. It discusses quantitative approaches to safety evaluation and risk management in drug development, covering Bayesian methods, effective safety graphics, and risk-benefit evaluation. Written by a team of experienced leaders, this book brings the most advanced knowledge and statistical methods of drug safety to the statistical, clinical, and safety community. It shares best practices and stimulates further research and methodology development in the drug safety area. Nº de ref. de la librería AA69781466555457

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Descripción Taylor and Francis 2014-12-11, Boca Raton, 2014. hardback. Estado de conservación: New. Nº de ref. de la librería 9781466555457

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Descripción Chapman and Hall/CRC, 2014. Hardback. Estado de conservación: NEW. 9781466555457 This listing is a new book, a title currently in-print which we order directly and immediately from the publisher. Nº de ref. de la librería HTANDREE0831635

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Descripción Chapman and Hall/CRC, 2014. Hardcover. Estado de conservación: New. book. Nº de ref. de la librería M1466555459

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Descripción Taylor Francis Inc, United States, 2014. Hardback. Estado de conservación: New. Language: English . This book usually ship within 10-15 business days and we will endeavor to dispatch orders quicker than this where possible. Brand New Book. State-of-the-Art Methods for Drug Safety Assessment Responding 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, and academia. It discusses quantitative approaches to safety evaluation and risk management in drug development, covering Bayesian methods, effective safety graphics, and risk-benefit evaluation. Written by a team of experienced leaders, this book brings the most advanced knowledge and statistical methods of drug safety to the statistical, clinical, and safety community. It shares best practices and stimulates further research and methodology development in the drug safety area. Nº de ref. de la librería BTE9781466555457

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Descripción Chapman and Hall/CRC, 2014. Hardcover. Estado de conservación: New. Never used!. Nº de ref. de la librería P111466555459

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Descripción Chapman & Hall, 2014. Hardcover. Estado de conservación: Brand New. 1st edition. 349 pages. 9.25x6.25x0.75 inches. In Stock. Nº de ref. de la librería __1466555459

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Descripción 2014. Hardcover. Estado de conservación: New. Hardcover. State-of-the-Art Methods for Drug Safety Assessment Responding to the increased scrutiny of drug safety in recent years, Quantitative Evaluation of Safety in Drug Development:.Shipping may be from our Sydney, NSW warehouse or from our UK or US warehouse, depending on stock availability. 382 pages. 0.658. Nº de ref. de la librería 9781466555457

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