{"product_id":"ligand-binding-assays-development-validation-and-implementation-in-the-drug-development-arena-9780470041383","title":"Ligand-Binding Assays: Development, Validation, and Implementation in the Drug Development Arena","description":"\u003cb\u003eA consolidated and comprehensive reference on ligand-binding assays\u003c\/b\u003e \u003cp\u003eLigand-binding assays (LBAs) stand as the cornerstone of support for definition of the pharmaco-kinetics and toxicokinetics of macromolecules, an area of burgeoning interest in the pharmaceutical industry. Yet, outside of the Crystal City Conference proceedings, little guidance has been available for LBA validation, particularly for assays used to support macromolecule drug development. \u003ci\u003eLigand-Binding Assays: Development, Validation, and Implementation in the Drug Development Arena\u003c\/i\u003e answers that growing need, serving as a reference text discussing critical aspects of the development, validation, and implementation of ligand-binding assays in the drug development field.\u003c\/p\u003e \u003cp\u003e\u003ci\u003eLigand-Binding Assays\u003c\/i\u003e covers essential topics related to ligand-binding assays, from pharmacokinetic studies, the development of LBAs, assay validation, statistical LBA aspects, and regulatory aspects, to software for LBAs and robotics and other emerging methodologies for LBAs. Highlights include: \u003c\/p\u003e \u003cul\u003e \u003cli\u003e \u003cp\u003eA general discussion of challenges and proven approaches in the development of ligand-binding assays\u003c\/p\u003e \u003c\/li\u003e \u003cli\u003e \u003cp\u003eMore detailed examination of characteristics of these assays when applied to support of pharmacokinetic and toxicokinetic studies of compounds at different stages in the discovery or development timeline\u003c\/p\u003e \u003c\/li\u003e \u003cli\u003e \u003cp\u003eA concise, but detailed, discussion of validation of ligand-binding assays for macromolecules\u003c\/p\u003e \u003c\/li\u003e \u003cli\u003e \u003cp\u003eA practical approach to \"fit-for-purpose\" validation of assays for biomarkers, those molecules receiving increased attention as potentially demonstrating that the target chosen in discovery is being modulated by the candidate therapeutic, both in nonclinical and clinical studies\u003c\/p\u003e \u003c\/li\u003e \u003c\/ul\u003e \u003cp\u003eWritten by a team of world-recognized authorities in the field, \u003ci\u003eLigand-Binding Assays\u003c\/i\u003e provides key information to a broad range of practitioners, both in the pharmaceutical and allied industries and in related contract research organizations and academic laboratories and, perhaps, even in the field of diagnostics and clinical chemistry.\u003c\/p\u003e\u003cbr\u003e\u003cbr\u003e\u003cb\u003eAuthor:\u003c\/b\u003e John W. a. Findlay\u003cbr\u003e\u003cb\u003ePublisher:\u003c\/b\u003e Wiley\u003cbr\u003e\u003cb\u003ePublished:\u003c\/b\u003e 11\/01\/2009\u003cbr\u003e\u003cb\u003ePages:\u003c\/b\u003e 432\u003cbr\u003e\u003cb\u003eBinding Type:\u003c\/b\u003e Hardcover\u003cbr\u003e\u003cb\u003eWeight:\u003c\/b\u003e 1.65lbs\u003cbr\u003e\u003cb\u003eSize:\u003c\/b\u003e 9.30h x 6.30w x 0.90d\u003cbr\u003e\u003cb\u003eISBN:\u003c\/b\u003e 9780470041383\u003cbr\u003e\u003cbr\u003e\u003cb\u003eReview Citation(s): \u003c\/b\u003e\u003cbr\u003e\u003ci\u003eScitech Book News\u003c\/i\u003e 03\/01\/2010 pg. 115\u003cbr\u003e\u003cp\u003e\u003cb\u003eAbout the Author\u003c\/b\u003e\u003cbr\u003e\u003cb\u003eMasood N. Khan, PhD\u003c\/b\u003e, received his PhD from Aligarh Muslim University, India, and did postdoctoral research at the National Institute of Environmental Health Sciences, Research Triangle Park, North Carolina, in immunology and cell biology. He subsequently moved to McGill University, Montreal, Canada, and served as assistant professor in the Department of Medicine. In 1988, he established and successfully directed the Ligand-Binding Assay Bioanalytical (LBAB) Department at Phoenix International Life Sciences (currently MDS Life Sciences), Montreal. Dr. Khan is a founding member of the LBAB Focus Group at AAPS and has coauthored authoritative reviews on validation of LBA and biomarker assays. He has over 100 publications and presentations to his credit. He is currently the Chief Scientist at GLP Solutions Inc. in Rockville, Maryland. \u003c\/p\u003e\u003cp\u003e\u003cb\u003eJohn W. A. Findlay, PhD, \u003c\/b\u003e earned his PhD from the University of Aberdeen, Scotland, and did postdoctoral work in organic and medicinal chemistry at the University of Virginia. He has extensive experience in successful drug development with several major pharmaceutical companies, particularly in the areas of bioanalysis and drug disposition. Dr. Findlay was a participant in the first AAPS\/FDA workshop on bioanalytical method validation in 1990 and in subsequent AAPS\/FDA workshops on this topic, as well as a coauthor of a guiding review article in this field published in 2000. Dr. Findlay has coauthored more than 140 original papers, reviews, book chapters, patents, and abstracts. He is currently a Senior Director in Clinical Pharmacology at Gilead Sciences in Durham, North Carolina.\u003c\/p\u003e\u003cbr\u003e\u003cp\u003e\u003ci\u003eThis title is not returnable\u003c\/i\u003e\u003cbr\u003e\u003c\/p\u003e","brand":"Wiley","offers":[{"title":"Hardcover","offer_id":40626652119155,"sku":"9.78047E+12","price":247.08,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0555\/9255\/0515\/products\/img_85909f6d-9010-475c-9219-d5ee5bce0b12.jpg?v=1671030778","url":"https:\/\/bookstorenmore.com\/products\/ligand-binding-assays-development-validation-and-implementation-in-the-drug-development-arena-9780470041383","provider":"Bookstore N More","version":"1.0","type":"link"}