{"product_id":"ethical-and-scientific-issues-in-institute-of-medicine-9780309218139","title":"Ethical and Scientific Issues in Studying the Safety of Approved Drugs","description":"\u003cp\u003eAn estimated 48 percent of the population takes at least one prescription drug in a given month. Drugs provide great benefits to society by saving or improving lives. Many drugs are also associated with side effects or adverse events, some serious and some discovered only after the drug is on the market. The discovery of new adverse events in the postmarketing setting is part of the normal natural history of approved drugs, and timely identification and warning about drug risks are central to the mission of the Food and Drug Administration (FDA). Not all risks associated with a drug are known at the time of approval, because safety data are collected from studies that involve a relatively small number of human subjects during a relatively short period.\u003c\/p\u003e \u003cp\u003eWritten in response to a request by the FDA, \u003cem\u003eEthical and Scientific Issues in Studying the Safety of Approved Drugs\u003c\/em\u003e discusses ethical and informed consent issues in conducting studies in the postmarketing setting. It evaluates the strengths and weaknesses of various approaches to generate evidence about safety questions, and makes recommendations for appropriate followup studies and randomized clinical trials. The book provides guidance to the FDA on how it should factor in different kinds of evidence in its regulatory decisions.\u003c\/p\u003e \u003cp\u003e\u003cem\u003eEthical and Scientific Issues in Studying the Safety of Approved Drugs \u003c\/em\u003ewill be of interest to the pharmaceutical industry, patient advocates, researchers, and consumer groups.\u003c\/p\u003e\u003cbr\u003e\u003cbr\u003e\u003cb\u003eAuthor:\u003c\/b\u003e Institute of Medicine,Board on Population Health and Public He,Committee on Ethical and Scientific Issu\u003cbr\u003e\u003cb\u003eISBN-10:\u003c\/b\u003e 0309218136\u003cbr\u003e\u003cb\u003eISBN-13:\u003c\/b\u003e 9780309218139\u003cbr\u003e\u003cb\u003ePublisher:\u003c\/b\u003e National Academies Press\u003cbr\u003e\u003cb\u003eLanguage:\u003c\/b\u003e English\u003cbr\u003e\u003cb\u003ePublished:\u003c\/b\u003e 12\/31\/2012\u003cbr\u003e\u003cb\u003ePages:\u003c\/b\u003e 292\u003cbr\u003e\u003cb\u003eFormat:\u003c\/b\u003e Paperback\u003cbr\u003e\u003cb\u003eWeight:\u003c\/b\u003e 1.05lbs\u003cbr\u003e\u003cb\u003eSize:\u003c\/b\u003e 8.90h x 6.00w x 0.80d","brand":"Institute of Medicine","offers":[{"title":"Paperback","offer_id":48064840696063,"sku":"9780309218139","price":55.0,"currency_code":"USD","in_stock":false}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0662\/2982\/9887\/files\/img_9c3bfb27-c2e7-4258-a070-6d451f78f5ea.jpg?v=1768671386","url":"https:\/\/www.whiterainbookhouse.com\/products\/ethical-and-scientific-issues-in-institute-of-medicine-9780309218139","provider":"WR Book House","version":"1.0","type":"link"}