{"product_id":"pharmaceutical-industry-practices-on-genotoxic-heewon-lee-9781439874202","title":"Pharmaceutical Industry Practices on Genotoxic Impurities","description":"\u003cp\u003eA great deal of confusion and uncertainty over genotoxic impurity (GTI) identification, assessment, and control exists in the pharmaceutical industry today. \u003cb\u003ePharmaceutical Industry Practices on Genotoxic Impurities \u003c\/b\u003estrives to facilitate scientific and systematic consensus on GTI management by presenting rationales, strategies, methods, interpretations, practices, and case studies from the pharmaceutical industry. Featuring the contributions of industry leaders from nine major pharmaceutical companies, this authoritative text: \u003c\/p\u003e\u003cul\u003e \u003cli\u003eExplores the safety, quality, and regulatory aspects of GTIs\u003c\/li\u003e \u003cli\u003eProvides an overview of the latest FDA and EMEA guidelines\u003c\/li\u003e \u003cli\u003eExplains the how and why of various GTI control tactics and practices\u003c\/li\u003e \u003cli\u003eDescribes genotoxicity evaluation, acceptable exposure calculation, and analytical methods for testing\u003c\/li\u003e \u003cli\u003eIncludes real-life examples of GTI control in drug substance and drug product development processes\u003c\/li\u003e \u003c\/ul\u003e\u003cp\u003eContaining case studies from large and small pharmaceutical firms in multiple geographical regions, \u003cb\u003ePharmaceutical Industry Practices on Genotoxic Impurities \u003c\/b\u003esupplies an overview of--and a current framework for--GTI control in the pharmaceutical industry, demonstrating how proper management of GTIs can occur with the appropriate guidance, a firm grasp of the practical implications, and effective information sharing between disciplines.\u003c\/p\u003e\u003cbr\u003e\u003cbr\u003e\u003cb\u003eAuthor:\u003c\/b\u003e Heewon Lee\u003cbr\u003e\u003cb\u003eISBN-10:\u003c\/b\u003e 1439874204\u003cbr\u003e\u003cb\u003eISBN-13:\u003c\/b\u003e 9781439874202\u003cbr\u003e\u003cb\u003ePublisher:\u003c\/b\u003e CRC Press\u003cbr\u003e\u003cb\u003eLanguage:\u003c\/b\u003e English\u003cbr\u003e\u003cb\u003ePublished:\u003c\/b\u003e 09\/04\/2014\u003cbr\u003e\u003cb\u003ePages:\u003c\/b\u003e 536\u003cbr\u003e\u003cb\u003eFormat:\u003c\/b\u003e Hardcover\u003cbr\u003e\u003cb\u003eWeight:\u003c\/b\u003e 1.95lbs\u003cbr\u003e\u003cb\u003eSize:\u003c\/b\u003e 9.20h x 6.10w x 1.30d","brand":"Heewon Lee","offers":[{"title":"Hardcover","offer_id":48447883575551,"sku":"9781439874202","price":255.0,"currency_code":"USD","in_stock":false}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0662\/2982\/9887\/files\/img_da803300-1c45-49b0-83c0-80feb60ff5c7.jpg?v=1777235454","url":"https:\/\/www.whiterainbookhouse.com\/products\/pharmaceutical-industry-practices-on-genotoxic-heewon-lee-9781439874202","provider":"WR Book House","version":"1.0","type":"link"}