{"product_id":"9780470281765","title":"Compatibility of Pharmaceutical Solutions and Contact Materials Safety Assessments of Extractables and Leachables for Pharmaceutical Products","description":"\u003ch1\u003eCompatibility of Pharmaceutical Solutions and Contact Materials\u003c\/h1\u003e\u003ch2\u003eSafety Assessments of Extractables and Leachables for Pharmaceutical Products\u003c\/h2\u003e\u003ch3\u003eDennis Jenke\u003c\/h3\u003e\u003cdiv\u003e\u003cb\u003eMedical \/ Pharmacology\u003c\/b\u003e\u003c\/div\u003e\u003cbr\u003e\u003cdiv\u003e\n\u003cp\u003e\u003cb\u003e\u003ci\u003eImportant safety aspects of compatibility for therapeutic products and their manufacturing systems, delivery devices, and containers\u003c\/i\u003e\u003c\/b\u003e  \u003c\/p\u003e\n\u003cp\u003e\u003ci\u003eCompatibility of Pharmaceutical Products and Contact Materials\u003c\/i\u003e helps pharmaceutical, toxicology, analytical, and regulatory affairs professionals assess the safety of leachable and extractable chemicals associated with drug product packaging, manufacturing systems, and devices. The most comprehensive resource available, its coverage includes the strategies, tactics, and regulatory requirements for performing safety assessments, along with the means for interpreting results. \u003c\/p\u003e\n\u003cp\u003eStructured around a logical framework for an extractables and leachables safety assessment and closely linked to the pharmaceutical product development process, \u003ci\u003eCompatibility of Pharmaceutical Products and Contact Materials\u003c\/i\u003e directly addresses the fundamental questions of \"what activities need to be performed to completely, efficiently, and effectively address the issue of product safety from an extractables and leachables perspective?\" and \"when do the various required activities need to be performed?\" Specifically, the chapters describe: \u003c\/p\u003e\n\u003cul\u003e \u003cli\u003ePertinent regulations and practical ways to meet guidelines\u003c\/li\u003e \u003cli\u003eCoordinating manufacturing, storage, and delivery systems development and qualification with therapeutic product development\u003c\/li\u003e \u003cli\u003eMaterials characterization and the materials screening process\u003c\/li\u003e \u003cli\u003eComponent and\/or system qualification (illustrated by several case studies)\u003c\/li\u003e \u003cli\u003ePerforming validation\/migration studies and interpreting and reporting the results\u003c\/li\u003e \u003cli\u003eCreating a product registration dossier and putting it through regulatory review\u003c\/li\u003e \u003cli\u003eProduct maintenance (Change Control) from an extractables and leachables perspective\u003c\/li\u003e \u003cli\u003eLikely future developments in extractables and leachables assessment\u003c\/li\u003e \u003c\/ul\u003e \u003cp\u003eAdditionally, the book's appendix provides a database, including CAS registry numbers, chemical formulas and molecular weights of extractable\/leachable substances that have been reported in the chemical literature. \u003c\/p\u003e\n\u003cp\u003eDetailing the interconnected roles played by analytical chemistry, biological science, toxicology, and regulatory science, \u003ci\u003eCompatibility of Pharmaceutical Products and Contact Materials\u003c\/i\u003e supplies a much-needed, comprehensive resource to all those in pharmaceutical product or medical device development.\u003c\/p\u003e\n\u003c\/div\u003e\u003cdiv\u003e  \u003cp\u003e\u003cb\u003eDENNIS JENKE\u003c\/b\u003e is Principal Scientist in the Technology Resources Division of the Baxter Healthcare Corporation. He works with a team of analytical chemistry professionals in areas including the assessment of material\/product compatibility, specifically with respect to leachables\/extractables and product ingredient binding. He has published extensively in the areas of analytical chemistry, environmental science, and material\/solution compatibility; serves as an expert reviewer for numerous pharmaceutical and analytical journals; is a frequently invited speaker in the general areas of analytical chemistry and material\/solution compatibility; and is currently an active participant in ongoing collaborative activities designed to establish harmonized best demonstrated practices for extractables\/leachables assessment. \u003c\/p\u003e\n\u003c\/div\u003e\u003cbr\u003e\u003ctable\u003e\n\u003ctr\u003e\n\u003ctd\u003ePublication Date: \u003c\/td\u003e\n\u003ctd\u003e02 June 2009\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\u003e9780470281765\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\u003e400\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003eWeight (oz): \u003c\/td\u003e\n\u003ctd\u003e23.2\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003c\/table\u003e","brand":"Wiley","offers":[{"title":"Default Title","offer_id":44310511026316,"sku":"9780470281765","price":145.76,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0710\/9545\/1788\/files\/9780470281765.jpg?v=1780160755","url":"https:\/\/fh90cf-fv.myshopify.com\/products\/9780470281765","provider":"Late Knight Books and Services, LLC","version":"1.0","type":"link"}