LEADER 03935nam 22006015 450 001 9910300234003321 005 20200706162641.0 010 $a3-319-15805-8 024 7 $a10.1007/978-3-319-15805-1 035 $a(CKB)3710000000402808 035 $a(EBL)2094447 035 $a(SSID)ssj0001501358 035 $a(PQKBManifestationID)11830589 035 $a(PQKBTitleCode)TC0001501358 035 $a(PQKBWorkID)11524805 035 $a(PQKB)10008941 035 $a(DE-He213)978-3-319-15805-1 035 $a(MiAaPQ)EBC2094447 035 $a(PPN)185485588 035 $a(EXLCZ)993710000000402808 100 $a20150421d2015 u| 0 101 0 $aeng 135 $aur|n|---||||| 181 $ctxt 182 $cc 183 $acr 200 10$aBenefit-Risk Assessment of Medicines$b[electronic resource] $eThe Development and Application of a Universal Framework for Decision-Making and Effective Communication /$fby James Leong, Sam Salek, Stuart Walker 205 $a1st ed. 2015. 210 1$aCham :$cSpringer International Publishing :$cImprint: Adis,$d2015. 215 $a1 online resource (326 p.) 300 $aDescription based upon print version of record. 311 $a3-319-15804-X 320 $aIncludes bibliographical references. 327 $aPrologue -- 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. 330 $aThis 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. 606 $aPharmacy 606 $aMedical research 606 $aDrug Safety and Pharmacovigilance$3https://scigraph.springernature.com/ontologies/product-market-codes/H69010 606 $aQuality of Life Research$3https://scigraph.springernature.com/ontologies/product-market-codes/H65000 615 0$aPharmacy. 615 0$aMedical research. 615 14$aDrug Safety and Pharmacovigilance. 615 24$aQuality of Life Research. 676 $a306 676 $a353998 676 $a610 700 $aLeong$b James$4aut$4http://id.loc.gov/vocabulary/relators/aut$0789311 702 $aSalek$b Sam$4aut$4http://id.loc.gov/vocabulary/relators/aut 702 $aWalker$b Stuart$4aut$4http://id.loc.gov/vocabulary/relators/aut 906 $aBOOK 912 $a9910300234003321 996 $aBenefit-Risk Assessment of Medicines$92512372 997 $aUNINA