{"product_id":"emerging-safety-science-institute-of-medicine-9780309110129","title":"Emerging Safety Science: Workshop Summary","description":"\u003cp\u003eIn recent years, the costs of new drug development have skyrocketed. The average cost of developing a new approved drug is now estimated to be $1.3 billion (DiMasi and Grabowski, 2007). At the same time, each year fewer new molecular entities (NMEs) are approved. DiMasi and Grabowski report that only 21.5 percent of the candidate drugs that enter phase I clinical testing actually make it to market. In 2007, just 17 novel drugs and 2 novel biologics were approved. In addition to the slowing rate of drug development and approval, recent years have seen a number of drugs withdrawn from the market for safety reasons. According to the Government Accountability Office (GAO), 10 drugs were withdrawn because of safety concerns between 2000 and March 2006 (GAO, 2006). Finding ways to select successful drug candidates earlier in development could save millions or even billions of dollars, reduce the costs of drugs on the market, and increase the number of new drugs with improved safety profiles that are available to patients.\u003c\/p\u003e Emerging scientific knowledge and technologies hold the potential to enhance correct decision making for the advancement of candidate drugs. Identification of safety problems is a key reason that new drug development is stalled. Traditional methods for assessing a drug's safety prior to approval are limited in their ability to detect rare safety problems. Prior to receiving U.S. Food and Drug Administration (FDA) approval, a drug will have been tested in hundreds to thousands of patients. Generally, drugs cannot confidently be linked to safety problems until they have been tested in tens of thousands to hundreds of thousands of people. With current methods, it is unlikely that rare safety problems will be identified prior to approval. \u003cem\u003eEmerging Safety Science: Workshop Summary\u003c\/em\u003e summarizes the events and presentations of the workshop.\u003cbr\u003e\u003cbr\u003e\u003cb\u003eAuthor:\u003c\/b\u003e Institute of Medicine,Board on Health Sciences Policy,Forum on Drug Discovery Development and\u003cbr\u003e\u003cb\u003eISBN-10:\u003c\/b\u003e 0309110122\u003cbr\u003e\u003cb\u003eISBN-13:\u003c\/b\u003e 9780309110129\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 05\/08\/2008\u003cbr\u003e\u003cb\u003ePages:\u003c\/b\u003e 150\u003cbr\u003e\u003cb\u003eFormat:\u003c\/b\u003e Paperback\u003cbr\u003e\u003cb\u003eWeight:\u003c\/b\u003e 0.60lbs\u003cbr\u003e\u003cb\u003eSize:\u003c\/b\u003e 8.90h x 6.00w x 0.40d\u003cbr\u003e\u003cbr\u003e\u003cb\u003eReview Citation(s): \u003c\/b\u003e\u003cbr\u003e\u003ci\u003eScitech Book News\u003c\/i\u003e 12\/01\/2008 pg. 119","brand":"Institute of Medicine","offers":[{"title":"Paperback","offer_id":48447635063039,"sku":"9780309110129","price":49.0,"currency_code":"USD","in_stock":false}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0662\/2982\/9887\/files\/img_6f869025-167f-4fe2-8667-57ca6ebef657.jpg?v=1777234009","url":"https:\/\/www.whiterainbookhouse.com\/products\/emerging-safety-science-institute-of-medicine-9780309110129","provider":"WR Book House","version":"1.0","type":"link"}