Quantitative Evaluation of Safety in Drug Development: by Qi Jiang, H. Amy Xia

By Qi Jiang, H. Amy Xia

State-of-the-Art equipment for Drug defense Assessment

Responding to the elevated scrutiny of drug safeguard in recent times, Quantitative review of safeguard in Drug improvement: layout, research and Reporting explains layout, tracking, research, and reporting matters for either medical trials and observational stories in biopharmaceutical product improvement. It offers the most recent statistical tools for drug safeguard evaluation.

The book’s 3 sections concentrate on research layout, security tracking, and information evaluation/analysis. The ebook addresses key demanding situations throughout regulatory companies, undefined, and academia. It discusses quantitative methods to defense review and possibility administration in drug improvement, overlaying Bayesian equipment, potent safeguard photos, and risk-benefit evaluation.

Written by means of a group of skilled leaders, this booklet brings the main complex wisdom and statistical tools of drug protection to the statistical, scientific, and security neighborhood. It stocks most sensible practices and stimulates extra learn and technique improvement within the drug safeguard area.

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Additional info for Quantitative Evaluation of Safety in Drug Development: Design, Analysis and Reporting

Sample text

Abrams, K. , and Myles, J. P. (2004) Bayesian Approaches to Clinical Trials and Health-Care Evaluation. New York: Wiley. Sutton, A. , Cooper, N. , Jones, D. , Lambert, P. , Thompson, J. , and Abrams, K. R. (2007) Evidence-based sample size calculations based upon updated metaanalysis, Statistics in Medicine 26, 2479–2500. The Action to Control Cardiovascular Risk in Diabetes Study Group. (2008) Effects of intensive glucose lowering in type 2 diabetes, The New England Journal of Medicine 358, 2545–2559.

5 Demonstrating Non-Inferiority and Superiority......................... 6 Choice of the Metric......................................................................... 7 Ethics................................................................................................... 3 Examples........................................................................................................ 50 References................................................................................................................

Gilks, W. R. and Wild, P. (1992) Adaptive rejection sampling for Gibbs sampling, Applied Statistics 41, 337–348. Ibrahim, J. G. -H. (2000) Power prior distributions for regression models, Statistical Sciences 15, 46–60. Ibrahim, J. , and Sinha, D. (2001) Bayesian Survival Analysis. New York: Springer-Verlag. Ibrahim, J. , Xia, H. , and Liu, T. (2012) Bayesian meta-experimental design: Evaluating cardiovascular risk in new antidiabetic therapies to treat type 2 diabetes, Biometrics 68, 578–586. Inoue, L.

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