{"product_id":"9780470108840","title":"Preclinical Safety Evaluation of Biopharmaceuticals A Science-Based Approach to Facilitating Clinical Trials","description":"\u003ch1\u003ePreclinical Safety Evaluation of Biopharmaceuticals\u003c\/h1\u003e\u003ch2\u003eA Science-Based Approach to Facilitating Clinical Trials\u003c\/h2\u003e\u003ch3\u003eJoy A. Cavagnaro\u003c\/h3\u003e\u003cdiv\u003e\u003cb\u003eMedical \/ Pharmacology\u003c\/b\u003e\u003c\/div\u003e\u003cbr\u003e\u003cdiv\u003e\"The goal is to provide a comprehensive reference book for the preclinicaldiscovery and development scientist whose responsibilities span target identification, lead candidate selection, pharmacokinetics, pharmacology, and toxicology, and for regulatory scientists whose responsibilities include the evaluation of novel therapies.\"\u003cbr\u003e —From the Afterword by Anthony D. Dayan\u003cbr\u003e \u003cbr\u003e Proper preclinical safety evaluation can improve the predictive value, lessen the time and cost of launching new biopharmaceuticals, and speed potentially lifesaving drugs to market. This guide covers topics ranging from lead candidate selection to establishing proof of concept and toxicity testing to the selection of the first human doses. With chapters contributed by experts in their specific areas, \u003ci\u003ePreclinical Safety Evaluation of Biopharmaceuticals: A Science-Based Approach to Facilitating Clinical Trials\u003c\/i\u003e:  \u003cul\u003e \u003cli\u003eIncludes an overview of biopharmaceuticals with information on regulation and methods of production\u003c\/li\u003e \u003cli\u003eDiscusses the principles of ICH S6 and their implementation in the U.S., Europe, and Japan\u003c\/li\u003e \u003cli\u003eCovers current practices in preclinical development and includes a comparison of safety assessments for small molecules with those for biopharmaceuticals\u003c\/li\u003e \u003cli\u003eAddresses all aspects of the preclinical evaluation process, including: the selection of relevant species; safety\/toxicity endpoints; specific considerations based upon class; and practical considerations in the design, implementation, and analysis of biopharmaceuticals\u003c\/li\u003e \u003cli\u003eCovers transitioning from preclinical development to clinical trials\u003c\/li\u003e \u003c\/ul\u003e This is a hands-on, straightforward reference for professionals involved in preclinical drug development, including scientists, toxicologists, project managers, consultants, and regulatory personnel.\u003c\/div\u003e\u003cdiv\u003e \u003cb\u003eJoy A. Cavagnaro,\u003c\/b\u003e PhD, is the President of Access BIO, a consultancy specializing in science-based regulatory strategies and product development services. She has over twenty-five years of experience in biotech spanning academia, the CRO and biotech industries, and government. During her tenure at the FDA, Dr. Cavagnaro served as rapporteur for ICH S6. She is founder and past chair of the BIO Preclinical Safety Expert Group (BioSafe) and was the U.S. BIO Representative to the 2006 ABPI\/BIA Early Stage Clinical Trials Taskforce.Dr. Cavagnaro is currently North American Chair of the Drug Information Association–Biotech SIAC and Chair of the Clinical and Regulatory Affairs Committee of the American Society of Gene Therapy. She serves on a number of scientific advisory boards and lectures internationally in the area of preclinical development of novel therapies.\u003c\/div\u003e\u003cbr\u003e\u003ctable\u003e\n\u003ctr\u003e\n\u003ctd\u003ePublication Date: \u003c\/td\u003e\n\u003ctd\u003e11 August 2008\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003ePublisher: \u003c\/td\u003e\n\u003ctd\u003eWiley\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003eImprint: \u003c\/td\u003e\n\u003ctd\u003eWiley-Interscience\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003eISBN-13: \u003c\/td\u003e\n\u003ctd\u003e9780470108840\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003eFormat: \u003c\/td\u003e\n\u003ctd\u003eHardback\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003ePage Count: \u003c\/td\u003e\n\u003ctd\u003e1080\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003eWeight (oz): \u003c\/td\u003e\n\u003ctd\u003e58.08\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003c\/table\u003e","brand":"Wiley","offers":[{"title":"Default Title","offer_id":44378641236108,"sku":"9780470108840","price":212.36,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0710\/9545\/1788\/files\/9780470108840_01025113-f3c4-4063-b16e-76c420acee2c.jpg?v=1780145424","url":"https:\/\/lateknightbooks.com\/products\/9780470108840","provider":"Late Knight Books and Services, LLC","version":"1.0","type":"link"}