Benefit-Risk Assessment of Medicines

Benefit-Risk Assessment of Medicines
Author :
Publisher : Springer
Total Pages : 326
Release :
ISBN-10 : 9783319158051
ISBN-13 : 3319158058
Rating : 4/5 (058 Downloads)

Book Synopsis Benefit-Risk Assessment of Medicines by : James Leong

Download or read book Benefit-Risk Assessment of Medicines written by James Leong and published by Springer. This book was released on 2015-04-21 with total page 326 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book proposes and investigates a universal framework, and accompanying documentation system, to facilitate and catalogue benefit-risk decisions; a valuable addition to the benefit-risk toolbox. Over the past decade, pharmaceutical companies and regulatory agencies have been reviewing the benefit-risk assessment of medicines with a view to developing a structured, systematic, standardized approach. Examining the evaluation of such an approach by several mature regulatory authorities ensures that the reader gains a unique insight into the ongoing debate in this area. The field of benefit-risk assessment continues to evolve at a rapid pace due to political and societal pressure, as is reflected in the recent FDA PUDFA agreement as well as in the EMA 2015 Roadmap. Rather than provide a comprehensive snap-shot of this constantly changing environment, this book evaluates selected current approaches to benefit-risk assessment. The strengths and weaknesses of publicly available documents in communicating benefit-risk decisions to stakeholders are reviewed and these evaluations are used to inform development of a prospective framework that could be used to harmonise procedures globally.

Benefit-Risk Assessment of Medicines Related Books

Benefit-Risk Assessment of Medicines
Language: en
Pages: 326
Authors: James Leong
Categories: Medical
Type: BOOK - Published: 2015-04-21 - Publisher: Springer

GET EBOOK

This book proposes and investigates a universal framework, and accompanying documentation system, to facilitate and catalogue benefit-risk decisions; a valuable
Benefit-Risk Assessment in Pharmaceutical Research and Development
Language: en
Pages: 216
Authors: Andreas Sashegyi
Categories: Mathematics
Type: BOOK - Published: 2013-11-27 - Publisher: CRC Press

GET EBOOK

Many practitioners in the pharmaceutical industry are still largely unfamiliar with benefit-risk assessment, despite its growing prominence in drug development
Therapeutic Risk Management of Medicines
Language: en
Pages: 435
Authors: Stephen J. Mayall
Categories: Medical
Type: BOOK - Published: 2014-04-16 - Publisher: Elsevier

GET EBOOK

Therapeutic risk management of medicines is an authoritative and practical guide on developing, implementing and evaluating risk management plans for medicines
The Risks of Prescription Drugs
Language: en
Pages: 179
Authors: Donald Light
Categories: Business & Economics
Type: BOOK - Published: 2010 - Publisher: Columbia University Press

GET EBOOK

Few people realize that prescription drugs have become a leading cause of death, disease, and disability. Adverse reactions to widely used drugs, such as psycho
Powerful Medicines
Language: en
Pages: 476
Authors: Jerry Avorn, M.D.
Categories: Medical
Type: BOOK - Published: 2008-12-10 - Publisher: Vintage

GET EBOOK

If you believe that the latest blockbuster medication is worth a premium price over your generic brand, or that doctors have access to all the information they