04489nam 2200685Ia 450 991097485940332120251116220309.00-309-17976-91-280-94146-497866109414690-309-10739-3(CKB)1000000000478359(EBL)3378272(SSID)ssj0000264704(PQKBManifestationID)11256329(PQKBTitleCode)TC0000264704(PQKBWorkID)10291612(PQKB)10815423(MiAaPQ)EBC3378272(Au-PeEL)EBL3378272(CaPaEBR)ebr10194174(OCoLC)923277273(BIP)53859133(BIP)14323448(EXLCZ)99100000000047835920070827d2007 uy 0engurcn|||||||||txtccrUnderstanding the benefits and risks of pharmaceuticals workshop summary, Forum on Drug Discovery, Development, and Translation, Board on Health Sciences Policy /Leslie Pray, rapporteur ; Institute of Medicine of the National Academies1st ed.Washington, D.C. National Academies Pressc20071 online resource (97 p.)Description based upon print version of record.0-309-10738-5 Includes bibliographical references.""Front Matter""; ""Reviewers""; ""Contents""; ""Summary""; ""1 Introduction""; ""2 Regulatory Assessment""; ""3 The Challenge of Communication""; ""4 The Importance of Context in Healthcare Decision Making""; ""5 Patient Experience with Drugs over Time""; ""6 Next Steps""; ""References""; ""Appendixes""; ""A Workshop Agenda""; ""B Discussion Leader and Speaker Biographies""All pharmaceutical products have inherent risks, and their use involves trade-offs between their therapeutic benefits and their risks. However, the public has a limited understanding of the benefits and risks of drugs, and many individuals believe that drugs approved by the U.S. Food and Drug Administration (FDA) carry no risks. The FDA is responsible for evaluating and balancing the potential risks of drugs with their potential benefits. Assessing, managing, and communicating the benefit-risk profile of a pharmaceutical product is a complex and nuanced scientific, political, and sociological challenge. Once the assessment is made, the FDA is then responsible for managing how to communicate these risks and make healthcare decisions based on them. To explore these issues, the Forum on Drug Discovery, Development, and Translation conducted a public workshop entitled Understanding the Benefits and Risks of Pharmaceuticals, with the broad goals of gaining a better understanding of the current system used to evaluate benefit and risk, and to identify opportunities for improvement. This workshop was held in Washington, D.C., on May 30-31, 2006. The benefit-risk profiles of pharmaceuticals are constantly evolving as new data are collected throughout the life cycle of a drug. Discussions during the workshop focused on the following: (1) premarket assessment, during which clinical trial data are used to assess benefit and risk; (2) communication of that information to prescribing physicians and their patients; (3) healthcare decisions made by prescribing physicians and their patients; and (4) the accumulation of benefit-risk information from postmarketing experience, which feeds back into the other phases. Understanding the Benefits and Risks of Pharmaceuticals: Workshop Summary explains in detail the discussions during this workshop.Benefits and risks of pharmaceuticalsForum on Drug Discovery, Development, and TranslationDrugsCongressesDrugsSide effectsCongressesChemotherapyCongressesChemotherapySide effectsCongressesDrugsDrugsSide effectsChemotherapyChemotherapySide effects615Pray Leslie A880793Institute of Medicine (U.S.).Forum on Drug Discovery, Development, and Translation.MiAaPQMiAaPQMiAaPQBOOK9910974859403321Understanding the benefits and risks of pharmaceuticals4469502UNINA02881nam 22006614a 450 991096053690332120251116173505.00-429-23458-91-134-44153-31-280-07539-20-203-64443-3(CKB)1000000000254839(EBL)200172(OCoLC)437060234(SSID)ssj0000299841(PQKBManifestationID)11254075(PQKBTitleCode)TC0000299841(PQKBWorkID)10242823(PQKB)11743572(MiAaPQ)EBC200172(Au-PeEL)EBL200172(CaPaEBR)ebr10098753(CaONFJC)MIL7539(EXLCZ)99100000000025483920030611d2004 uy 0engur|n|---|||||txtccrThe Institute of Accounts nineteenth-century origins of accounting professionalism in the United States /Stephen E. Loeb and Paul J. Miranti, Jr1st ed.London ;New York Routledge20041 online resource (123 p.)Routledge new works in accounting history ;1Monograph series of the Academy of Accounting Historians ;9Description based upon print version of record.1-138-87941-X 0-415-28874-6 Includes bibliographical references (p. [68]-102) and index.Origins, goals, and membership, and professional characteristics -- Functionality of the IA and its role in professionalization -- The structure of accounting knowledge and the natural order of society -- Decline of the IA -- Legacy.This book focuses upon the Institute of Accounts (IA), an organization to which the modern United States accounting profession can trace its roots. The IA was organized in the early 1880s in New York City and, as discussed in this book, attracted a diverse membership that included some of the leading accounting thinkers of the period. The Institute of Accounts describes the association's early development, its usefulness to the needs of bookkeepers and accountants in the late nineteenth century, and its historical importance.Monograph (Academy of Accounting Historians) ;9.Routledge new works in accounting history ;1.AccountantsUnited StatesAccountantsProfessional ethicsUnited StatesAccountantsAccountantsProfessional ethics657/.06/073Loeb Stephen E112100Miranti Paul J140805MiAaPQMiAaPQMiAaPQBOOK9910960536903321The Institute of Accounts4493092UNINA