{"product_id":"preclinical-safety-evaluation-of-biopharmaceuticals-a-sciencebased-approach-to-facilitating-clinical-trials-9780470108840","title":"Preclinical Safety Evaluation of Biopharmaceuticals: A Science-Based Approach to Facilitating Clinical Trials","description":"\u003cp\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.\" From the Afterword by Anthony D. Dayan  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  Preclinical Safety Evaluation of Biopharmaceuticals: A Science-Based Approach to Facilitating Clinical Trials: Includes an overview of biopharmaceuticals with information on regulation and methods of production Discusses the principles of ICH S6 and their implementation in the U.S.  Europe  and Japan Covers current practices in preclinical development and includes a comparison of safety assessments for small molecules with those for biopharmaceuticals Addresses 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 Covers transitioning from preclinical development to clinical trials This is a hands-on  straightforward reference for professionals involved in preclinical drug development  including scientists  toxicologists  project managers  consultants  and regulatory personnel.\u003c\/p\u003e","brand":"My Store","offers":[{"title":"Default Title","offer_id":45646905868341,"sku":"ByrdShop_0470108843","price":210.35,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0627\/8139\/0901\/files\/9780470108840.jpg?v=1781681016","url":"https:\/\/atxbooks.com\/products\/preclinical-safety-evaluation-of-biopharmaceuticals-a-sciencebased-approach-to-facilitating-clinical-trials-9780470108840","provider":"ATX Books","version":"1.0","type":"link"}