01349nam 2200325Ia 450 99639665440331620231026002629.0(CKB)4330000000332675(EEBO)2248543180(OCoLC)07916098(EXLCZ)99433000000033267519811107d1696 uy |engurbn#|||a|bb|The pleasant and princely history of the gentle-craft a discourse containing many matters of delight, very pleasant to read : shewing what famous men have been shoe-makers in time past in this land : with their worthy deeds ... declaring the cause why it was called the gentle-craft and also how the poverb [sic] first grew, A shoemaker's son is a prince born /T.DLondon Printed by W. Wilde, and sold by P. Brooksby [etc.]16961 online resource ([3], 51 p.) illCover title: The history of the gentle-craft.Reproduction of original in the Bodleian Library.eebo-0014ShoemakersEarly works to 1800ShoemakersDeloney Thomas1543?-1600.137560EEUEEUWaOLNLML996396654403316The pleasant and princely history of the gentle-craft2349404UNISA03947nam 22006135 450 991030023400332120250609112020.03-319-15805-810.1007/978-3-319-15805-1(CKB)3710000000402808(EBL)2094447(SSID)ssj0001501358(PQKBManifestationID)11830589(PQKBTitleCode)TC0001501358(PQKBWorkID)11524805(PQKB)10008941(DE-He213)978-3-319-15805-1(MiAaPQ)EBC2094447(PPN)185485588(MiAaPQ)EBC3110159(EXLCZ)99371000000040280820150421d2015 u| 0engur|n|---|||||txtccrBenefit-Risk Assessment of Medicines The Development and Application of a Universal Framework for Decision-Making and Effective Communication /by James Leong, Sam Salek, Stuart Walker1st ed. 2015.Cham :Springer International Publishing :Imprint: Adis,2015.1 online resource (326 p.)Description based upon print version of record.3-319-15804-X Includes bibliographical references.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.PharmacyMedicineResearchDrug Safety and Pharmacovigilancehttps://scigraph.springernature.com/ontologies/product-market-codes/H69010Quality of Life Researchhttps://scigraph.springernature.com/ontologies/product-market-codes/H65000Pharmacy.MedicineResearch.Drug Safety and Pharmacovigilance.Quality of Life Research.306353998610Leong Jamesauthttp://id.loc.gov/vocabulary/relators/aut789311Salek Samauthttp://id.loc.gov/vocabulary/relators/autWalker Stuartauthttp://id.loc.gov/vocabulary/relators/autBOOK9910300234003321Benefit-Risk Assessment of Medicines2512372UNINA