{"product_id":"9780470173657","title":"Leachables and Extractables Handbook Safety Evaluation, Qualification, and Best Practices Applied to Inhalation Drug Products","description":"\u003ch1\u003eLeachables and Extractables Handbook\u003c\/h1\u003e\u003ch2\u003eSafety Evaluation, Qualification, and Best Practices Applied to Inhalation Drug Products\u003c\/h2\u003e\u003ch3\u003eDouglas J. Ball | Daniel L. Norwood | Cheryl L. M. Stults | Lee M. Nagao\u003c\/h3\u003e\u003cdiv\u003e\u003cb\u003eScience \/ Chemistry \/ Industrial \u0026amp; Technical\u003c\/b\u003e\u003c\/div\u003e\u003cbr\u003e\u003cdiv\u003e\n\u003cp\u003eA practical and science-based approach for addressing toxicological concerns related to leachables and extractables associated with inhalation drug products\u003c\/p\u003e \u003cp\u003ePackaging and device components of Orally Inhaled and Nasal Drug Products (OINDP)—such as metered dose inhalers, dry powder inhalers, and nasal sprays—pose potential safety risks from leachables and extractables, chemicals that can be released or migrate from these components into the drug product. Addressing the concepts, background, historical use, and development of safety thresholds and their utility for qualifying leachables and extractables in OINDP, the Leachables and Extractables Handbook takes a practical approach to familiarize readers with the recent recommendations for safety and risk assessment established through a joint effort of scientists from the FDA, academia, and industry. Coverage includes best practices for the chemical evaluation and management of leachables and extractables throughout the pharmaceutical product life cycle, as well as:\u003c\/p\u003e \u003cul\u003e \u003cli\u003e \u003cp\u003eGuidance for pharmaceutical professionals to qualify and risk-assess container closure system leachables and extractables in drug products\u003c\/p\u003e \u003c\/li\u003e \u003cli\u003e \u003cp\u003ePrinciples for defining toxicological safety thresholds that are applicable to OINDP and potentially applicable to other drug products\u003c\/p\u003e \u003c\/li\u003e \u003cli\u003e \u003cp\u003eRegulatory perspectives, along with an appendix of key terms and definitions, case studies, and sample protocols\u003c\/p\u003e \u003c\/li\u003e \u003c\/ul\u003e \u003cp\u003eAnalytical chemists, packaging and device engineers, formulation development scientists, component suppliers, regulatory affairs specialists, and toxicologists will all benefit from the wealth of information offered in this important text.\u003c\/p\u003e\n\u003c\/div\u003e\u003cdiv\u003e  \u003cb\u003eDOUGLAS J. BALL\u003c\/b\u003e is a board-certified toxicologist (Diplomate of the American Board of Toxicology) and currently employed by Pfizer Inc. as a Research Fellow in drug safety R\u0026amp;D specializing in regulatory strategy and compliance. He chairs the Extractables and Leachables Safety Information Exchange (ELSIE) Board of Directors, and the Toxicology Team of the Product Quality Research Institute (PQRI) Leachables and Extractables Working Group for both OINDP and parenteral and ophthalmic drug products.  \u003cp\u003e\u003cb\u003eDANIEL L. NORWOOD\u003c\/b\u003e is a Distinguished Research Fellow in Analytical Development at Boehringer Ingelheim and has more than thirty-five years of professional experience. He chaired the PQRI Leachables and Extractables Working Group and is a thirty-two-year member of the American Chemical Society (ACS). Dr. Norwood is a member of the ELSIE Board of Directors.\u003c\/p\u003e \u003cp\u003e\u003cb\u003eCHERYL L. M. STULTS\u003c\/b\u003e is a Senior Fellow at Novartis Pharmaceuticals Corporation, focusing on materials analysis and characterization. She chairs the International Pharmaceutical Aerosol Consortium on Regulation and Science (IPAC-RS) Materials and Leachables and Extractables Working Groups and is a member of the ELSIE Board of Directors. Dr. Stults is a thirty-three year member of the ACS.\u003c\/p\u003e \u003cp\u003e\u003cb\u003eLEE M. NAGAO\u003c\/b\u003e is a Senior Science Advisor in the Pharmaceutical Practice Group at Drinker Biddle \u0026amp; Reath LLP. As a member of the IPAC-RS Secretariat, Dr. Nagao supports the Consortium's initiatives in materials quality, leachables and extractables, supplier quality, and foreign particles. She was a member of the PQRI OINDP Leachables and Extractables Working Group and serves as Science Advisor and Secretariat to the ELSIE Consortium. Dr. Nagao is a member of the ACS and the AAAS.\u003c\/p\u003e\n\u003c\/div\u003e\u003cbr\u003e\u003ctable\u003e\n\u003ctr\u003e\n\u003ctd\u003ePublication Date: \u003c\/td\u003e\n\u003ctd\u003e24 January 2012\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\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003eISBN-13: \u003c\/td\u003e\n\u003ctd\u003e9780470173657\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\u003e700\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003eWeight (oz): \u003c\/td\u003e\n\u003ctd\u003e38.4\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003c\/table\u003e","brand":"Wiley","offers":[{"title":"Default Title","offer_id":44315784413324,"sku":"9780470173657","price":144.85,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0710\/9545\/1788\/files\/9780470173657.jpg?v=1780153639","url":"https:\/\/lateknightbooks.com\/products\/9780470173657","provider":"Late Knight Books and Services, LLC","version":"1.0","type":"link"}