Quantitative evaluation of safety in drug development : design, analysis and reporting / edited by Qi Jiang, Amgen Inc, Thousand Oaks, California, USA, H. Amy Xi, Amgen Inc, Thousand Oaks, California, USA.

Format:

Book

Contributor:

Jiang, Qi (Biostatistician), editor.

Xia, H. Amy, editor.

CRC Press.

Arthur Bernstein Cardiology Library Fund.

Series:

Chapman & Hall/CRC biostatistics series (Unnumbered)

Chapman & Hall/CRC biostatistics series

Language:

English

Subjects (All):

Drugs--Testing--Statistical methods.

Drugs.

Drugs--Safety measures--Statistical methods.

Drug Evaluation.

Bayes Theorem.

Biostatistics--methods.

Drug Discovery.

Pharmacovigilance.

Drugs--Safety measures.

Statistics.

Drugs--Testing.

Medical Subjects:

Drug Evaluation.

Bayes Theorem.

Biostatistics--methods.

Drug Discovery.

Pharmacovigilance.

Physical Description:

1 online resource (xv, 349 pages, 16 unnumbered pages of plates) : illustrations (some color.

Place of Publication:

Boca Raton : CRC Press, Taylor & Francis Group, [2015]

System Details:

text file

Summary:

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. Features, Focuses on the quantitative evaluation of safety of biopharmaceutical products, Covers several Bayesian approaches, including a meta-experimental design for evaluating cardiovascular risk, adaptive trials for drug safety, and network meta-analysis for safety evaluation, Explains why a DMC safety report differs from a safety report written at the end of the trial, Describes the safety surveillance and signal detection process, Discusses the observational medical outcomes partnership (OMOP), Addresses regulatory issues in the meta-analysis of safety data, Presents safety evaluation and quantitative approaches during preclinical and early phases of drug development, 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. Book jacket.

Contents:

Incorporating quantitative safety evaluation into risk management / Jüergen Küebler

Bayesian metaexperimental design for evaluating cardiovascular risk / Joseph G. Ibrahim, Ming-Hui Chen, H. Amy Xia, Thomas Liu and Violeta Hennessey

Non-inferiority study design and analysis for safety endpoints / /Steven Snapinn and Qi Jiang

Program safety analysis plan : an implementation guide / Brenda Crowe, H. Amy Xia, Mary Nilsson, Seta Shahin, Wei Wang, and Qi Jiang

Why a DMC safety report differs from a safety section written at the end of the trial / Mark Schactman and Janet Wittes

Safety surveillance and signal detection process / Atsuko Shibata and José M. Vega

Bayesian adaptive trials for drug safety / Jason T. Connor

Observational safety study design, analysis, and reporting / Hong Qiu, Jesse A. Berlin, and Paul E. Stang

Emerging role of observational health-care data in pharmacovigilance / Patrick Ryan, David Madigan, and Martijn Schuemie

Roadmap for causal inference in safety analysis / Jordan C. Brooks, Alan S. Go, Daniel E. Singer, and Mark J. van der Laan

Safety graphics / Susan P. Duke, Qi Jiang, Liping Huang, Mary Banach, and Max Cherny

Bayesian network meta-analysis for safety evaluation / Bradley P. Carlin and Hwanhee Hong

Regulatory issues in meta-analysis of safety data / Aloka G. Chakravarty and Mark Levenson

Bayesian applications for drug safety evaluation / H. Amy Xia and Karen L. Price

Benefit-risk assessment approaches / Chunlei Ke, Qi Jiang, and Steven Snapinn

Detecting safety signals in subgroups / Christy Chuang-Stein, Yoichi Ii, Norisuke Kawai, Osamu Komiyama and Kazuhiko Kuribayashi

Overview of safety evaluation and quantitative approaches from preclinical and early phases of drug development / John Sullivan and Hisham Hamadeh.

Notes:

Includes bibliographical references and index.

Electronic reproduction. Boca Raton, FL Available via World Wide Web.

Description based on print version record.

Local Notes:

Acquired for the Penn Libraries with assistance from the Arthur Bernstein Cardiology Library Fund.

ISBN:

1466555475

9781466555471

Publisher Number:

99961855513

Access Restriction:

Restricted for use by site license.