Ethical and scientific issues in studying the safety of approved drugs
By: Committee on Ethical and Scientific Issues in Studying the Safety of Approved Drugs, Board on Population Health and Public Health Practice, Institute of Medicine of the National Academies
Publisher: National Academies Press
Published: 2012
Place of publication: Washington, D.C
Language: eng
ISBN-13: 9780309218139; 9780309218146
Subjects: Postmarketing Product Surveillance; Methods; Drug Evaluation; Ethics; Drug Approval; Clinical Trials as Topic
Notes: Includes bibliographical references and index.
Table of contents: title: Incorporating benefit and risk assessment and benefit/risk management into food and drug administration decision-making; title: Evidence and decision-making; title: Selection and oversight of required postmarketing studies; title: Synthesis.