Benefit-risk assessment of medicines : the development and application of a universal framework for decision-making and effective communication /: the development and application of a universal framework for decision-making and effective communication. ([2015])

• Record Type: Book
• Further Information: Note: James Leong, Sam Salek, Stuart Walker ; foreword by Hans-Georg Eichler.
• Editors: Leong, James; Salek, Sam; Walker, Stuart R, 1944-
• 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.
• Publisher Details: Cham : Springer
• Publication Date: 2015
• Extent: 1 online resource
• Subjects: 615/.1901; Medicine; Drugs -- Testing; Pharmaceutical policy -- Decision making; MEDICAL -- Pharmacology; Drugs -- Testing; Medicine & Public Health; Drug Safety and Pharmacovigilance; Quality of Life Research; Medical -- Public Health; Personal & public health; Quality of Life -- Research; Pharmacology; Electronic books
• Languages: English
• ISBNs: 9783319158051; 3319158058; 9783319158044
• Related ISBNs: 331915804X; 9783319158044
• Notes: Note: Includes bibliographical references.; Note: Vendor-supplied metadata.
• Access Rights: Legal Deposit; Only available on premises controlled by the deposit library and to one user at any one time; The Legal Deposit Libraries (Non-Print Works) Regulations (UK).
• Access Usage: Restricted: Printing from this resource is governed by The Legal Deposit Libraries (Non-Print Works) Regulations (UK) and UK copyright law currently in force.