{"product_id":"analytical-method-validation-lawrence-a-wilson-9798987021200","title":"Analytical Method Validation: QbD","description":"\u003cp\u003eThis book contains essays on data integrity.\u003c\/p\u003e\u003cp\u003eData integrity is the most basic element of work in any scientific discipline.\u003c\/p\u003e\u003cp\u003eNothing of lasting value in the hard sciences (physics, chemistry, biology, \u003c\/p\u003e\u003cp\u003eastronomy, et al.) lacks integrity in the data used to support the premises, \u003c\/p\u003e\u003cp\u003ethe logical arguments proposed, and the conclusions drawn. The point of\u003c\/p\u003e\u003cp\u003evalidation is, after all, to ensure that all results obtained and reported are\u003c\/p\u003e\u003cp\u003etrue.\u003c\/p\u003e\u003cp\u003eThe original premise of our book was to merge the global standard for\u003c\/p\u003e\u003cp\u003epharmaceutical analytical methods for regulatory applications [ICH\u003c\/p\u003e\u003cp\u003eQ2(R1)] with contemporary thinking on ensuring data quality by\u003c\/p\u003e\u003cp\u003ethoroughly understanding a method and its intended application (QbD).\u003c\/p\u003e\u003cp\u003eDuring a preproduction meeting, an incisive question led to expanding the\u003c\/p\u003e\u003cp\u003escope of the original five chapters: \"Can this be applied to fields other than\u003c\/p\u003e\u003cp\u003epharmaceuticals?\" The answer was: Yes.\u003c\/p\u003e\u003cp\u003eThree chapters were added to explore the applications of Quality by Design\u003c\/p\u003e\u003cp\u003etheory to real world problems that are bound not only by regulations, but by\u003c\/p\u003e\u003cp\u003ebusiness constraints, professional ethics, time, resources, and technology. They\u003c\/p\u003e\u003cp\u003emay serve as case studies for classes of advanced students.\u003c\/p\u003e\u003cp\u003eThe scientific approach is rigorous, drawing on, and integrating, classical wet\u003c\/p\u003e\u003cp\u003eand modern instrumental analytical chemistry knowledge. The reasoning is\u003c\/p\u003e\u003cp\u003edetailed and well-documented. Examples are carefully explained. Two are\u003c\/p\u003e\u003cp\u003ebased on historical events. The other is a problem that is not yet fully resolved\u003c\/p\u003e\u003cp\u003edespite its importance and significant risks to human health globally.\u003c\/p\u003e\u003cp\u003eThe tone throughout is conversational. It is intended to involve students -\u003c\/p\u003e\u003cp\u003eand any reader who has a vested interest in data integrity, which includes the\u003c\/p\u003e\u003cp\u003eglobal scientific communities from academia, industry, and government, and\u003c\/p\u003e\u003cp\u003eproducers and consumers of quantitative measurements and the goods and\u003c\/p\u003e\u003cp\u003eservices obtained by their use.\u003c\/p\u003e\u003cp\u003eThe objective is to impart an intuitive understanding of method validation: \u003c\/p\u003e\u003cp\u003eplanning, execution, and documentation, \u003c\/p\u003e\u003cp\u003ewith examples of practices and\u003c\/p\u003e\u003cp\u003eproblems, and with practical strategies for addressing both.\u003c\/p\u003e\u003cp\u003eA special feature is the inclusion of \"Hints\" - brief comments offering\u003c\/p\u003e\u003cp\u003eexperience-based advice acquired while developing, validating, reviewing, and\u003c\/p\u003e\u003cp\u003eauditing analytical methods (and data) in a variety of industries\u003c\/p\u003e\u003cp\u003eand countries.\u003c\/p\u003e\u003cbr\u003e\u003cbr\u003e\u003cb\u003eAuthor:\u003c\/b\u003e Lawrence A. Wilson, Carolyn M. Merkel\u003cbr\u003e\u003cb\u003eISBN-10:\u003c\/b\u003e 8987021203\u003cbr\u003e\u003cb\u003eISBN-13:\u003c\/b\u003e 9798987021200\u003cbr\u003e\u003cb\u003ePublisher:\u003c\/b\u003e Wessex, Inc.\u003cbr\u003e\u003cb\u003eLanguage:\u003c\/b\u003e English\u003cbr\u003e\u003cb\u003ePublished:\u003c\/b\u003e 12\/01\/2022\u003cbr\u003e\u003cb\u003ePages:\u003c\/b\u003e 218\u003cbr\u003e\u003cb\u003eFormat:\u003c\/b\u003e Hardcover\u003cbr\u003e\u003cb\u003eWeight:\u003c\/b\u003e 1.76lbs\u003cbr\u003e\u003cb\u003eSize:\u003c\/b\u003e 11.00h x 8.50w x 0.56d","brand":"Lawrence A. Wilson","offers":[{"title":"Hardcover","offer_id":44311251583231,"sku":"9798987021200","price":234.7,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0662\/2982\/9887\/files\/img_0609e840-e698-45f8-b2cc-8374780f2a32.jpg?v=1695721849","url":"https:\/\/www.whiterainbookhouse.com\/products\/analytical-method-validation-lawrence-a-wilson-9798987021200","provider":"WR Book House","version":"1.0","type":"link"}