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Title:
Benefit-Risk Assessment of Medicines The Development and Application of a Universal Framework for Decision-Making and Effective Communication
Author:
Leong, James. author.
ISBN:
9783319158051
Edition:
1st ed. 2015.
Physical Description:
XIII, 317 p. 163 illus., 138 illus. in color. online resource.
Contents:
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.
Added Corporate Author:
Electronic Access:
https://doi.org/10.1007/978-3-319-15805-1Copies:
Available:*
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Searching... | E-Book | 519993-1001 | XX(519993.1) | Searching... | Searching... |