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Benefit-Risk Assessment of Medicines = The Development and Application of a Universal Framework for Decision-Making and Effective Communication /

Record Type:	Language materials, printed : Monograph/item
Title/Author:	Benefit-Risk Assessment of Medicines/ by James Leong, Sam Salek, Stuart Walker.
Reminder of title:	The Development and Application of a Universal Framework for Decision-Making and Effective Communication /
Author:	Leong, James.
other author:	Salek, Sam.
Description:	XIII, 317 p. 163 illus., 138 illus. in color.online resource. :
Contained By:	Springer Nature eBook
Subject:	Pharmacy. -
Online resource:	https://doi.org/10.1007/978-3-319-15805-1
ISBN:	9783319158051

Benefit-Risk Assessment of Medicines = The Development and Application of a Universal Framework for Decision-Making and Effective Communication /
Leong, James.

Benefit-Risk Assessment of MedicinesThe Development and Application of a Universal Framework for Decision-Making and Effective Communication /[electronic resource] :by James Leong, Sam Salek, Stuart Walker. - 1st ed. 2015. - XIII, 317 p. 163 illus., 138 illus. in color.online resource.

Prologue -- Preface -- Overview -- Approaches to utilising decision-making framework -- Benefit-risk assessment of medicines by pharmaceutical companies and regulatory authorities -- Development of a universal benefit-risk framework and template -- Implementation of the benefit-risk assessment template by mature agencies -- Implementation of the benefit- risk summary template by a maturing agency: A case study -- Communicating benefit-risk decisions by US FDA, EMA, TGA and Health Canada -- Conclusions and future directions -- References.

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.

ISBN: 9783319158051

Standard No.: 10.1007/978-3-319-15805-1doiSubjects--Topical Terms:

582411
Pharmacy.

LC Class. No.: RS1-441

Dewey Class. No.: 353.998

Benefit-Risk Assessment of Medicines = The Development and Application of a Universal Framework for Decision-Making and Effective Communication /
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