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Paperback Benefit-Risk Assessment of Medicines: The Development and Application of a Universal Framework for Decision-Making and Effective Communication Book

ISBN: 3319367676

ISBN13: 9783319367675

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

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Format: Paperback

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Book Overview

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.

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