{"product_id":"generic-drug-product-development-isadore-kanfer-9780849377846","title":"Generic Drug Product Development: Bioequivalence Issues","description":"The assessment of bioequivalence is an important process whereby the bioavailability of a generic drug product is compared with its brand-name counterpart; generic pharmaceutical products must be approved as therapeutic equivalents to the brand name alternative in order to be interchangeable. The demonstration of bioequivalence is an important component of therapeutic equivalence. Bioequivalence studies are very expensive, time consuming and always have the possibility of failure. The objective of this textbook is to describe some of those specific bioequivalence issues which need to be considered for the design and conduct of a bioequivalence studies. By exploring scientific, legal, and international regulatory challenges, this source discusses the use of alternative approaches to the measurement of plasma drug concentrations for the demonstration of bioequivalence, and covers bioequivalence procedures for drug products that are not easily assessed - based upon the chemical composition of the active drug and the nature of the drug product..\u003cbr\u003e\u003cbr\u003e\u003cb\u003eAuthor:\u003c\/b\u003e Isadore Kanfer,Leon Shargel\u003cbr\u003e\u003cb\u003eISBN-10:\u003c\/b\u003e 0849377846\u003cbr\u003e\u003cb\u003eISBN-13:\u003c\/b\u003e 9780849377846\u003cbr\u003e\u003cb\u003ePublisher:\u003c\/b\u003e CRC Press\u003cbr\u003e\u003cb\u003eLanguage:\u003c\/b\u003e English\u003cbr\u003e\u003cb\u003ePublished:\u003c\/b\u003e 11\/15\/2007\u003cbr\u003e\u003cb\u003ePages:\u003c\/b\u003e 288\u003cbr\u003e\u003cb\u003eFormat:\u003c\/b\u003e Hardcover\u003cbr\u003e\u003cb\u003eWeight:\u003c\/b\u003e 1.12lbs\u003cbr\u003e\u003cb\u003eSize:\u003c\/b\u003e 9.04h x 6.41w x 0.75d","brand":"Isadore Kanfer","offers":[{"title":"Hardcover","offer_id":48449019183359,"sku":"9780849377846","price":245.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0662\/2982\/9887\/files\/img_038d666d-ff53-4377-9506-fbe17db393ce.jpg?v=1777261600","url":"https:\/\/www.whiterainbookhouse.com\/products\/generic-drug-product-development-isadore-kanfer-9780849377846","provider":"WR Book House","version":"1.0","type":"link"}