Ethical and scientific issues in studying the safety of approved drugs

Detalles Bibliográficos
Autores Corporativos:	Institute of Medicine (U.S.). Committee on Ethical and Scientific Issues in Studying the Safety of Approved Drugs (-), Institute of Medicine (U.S.). Board on Population Health and Public Health Practice, National Academies Press (U.S.)
Formato:	Libro electrónico
Idioma:	Inglés
Publicado:	Washington, D.C. : National Academies Press c2012.
Edición:	1st ed
Materias:	Drugs > Testing > Moral and ethical aspects > United States. Clinical trials > Moral and ethical aspects > United States. Drug approval > United States.
Ver en Biblioteca Universitat Ramon Llull:	https://discovery.url.edu/permalink/34CSUC_URL/1im36ta/alma991009607433506719

Tabla de Contenidos:

""Front Matter""; ""Reviewers""; ""Preface""; ""In Memoriam--Dr. Thomas Ten Have""; ""Contents""; ""Abstract""; ""Summary""; ""1 Introduction""; ""2 Incorporating Benefit and Risk Assessment and Benefit-Risk Management into Food and Drug Administration Decision-Making""; ""3 Evidence and Decision-Making""; ""4 Selection and Oversight of Required Postmarketing Studies""; ""5 Synthesis""; ""Appendix A: Other Elements of the Food and Drug Administration Amendments Act""; ""Appendix B: Committee's Letter Report""; ""Appendix C: Open Session Agendas""
""Appendix D: Decision Conferencing and Multicriteria Decision Analysis""""Appendix E: Benefit and Risk Assessment and Management Plan Document Template""; ""Appendix F: Committee Biosketches""

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