Benefit-Risk Appraisal of Medicines : A Systematic Approach to Decision-making

Written by renowned experts in the field, this book establishes the criteria required to assess benefit-risk in general and reviews the current practice of benefit-risk assessment by drug regulatory authorities and the pharmaceutical industry.

It outlines how the new MCDA model was developed and evaluated, and discusses the implications of its implementation into the practice of drug evaluation.

Comparisons are also made with existing benefit-risk models such as the 'Principle of Threes' and TURBO models.

It discusses a very topical subject in the wake of the withdrawal of the Cox-2 inhibitors and other high-profile withdrawals.

It includes risk-management plans. New MCDA model is relevant for the assessment of both, new compounds being presented for licence and the ongoing evaluation of existing drugs on the market.

MCDA model allows for all available efficacy and safety data to be evaluated. "Risk/Benefit Assessment in Medicine" is an invaluable resource for researchers, clinical trial managers, pharmacovigilance and epidemiology staff in the pharmaceutical industry.The book is also useful for drug regulatory authorities, and pharmaceutical medicine or medicinal chemistry departments at universities.