ISBN: 9780849377846 - generic drug product development: bioequivalence issues (drugs and the pharmaceutical sciences, 180, band 180) (19 Ergebnisse)

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Zustand: New. Dieser Artikel ist ein Print on Demand Artikel und wird nach Ihrer Bestellung fuer Sie gedruckt. Isadore Kanfer, Leon ShargelThe 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 equiv. …

Buch. Zustand: Neu. nach der Bestellung gedruckt Neuware - Printed after ordering - 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.…

Buch. Zustand: Neu. Generic Drug Product Development | Bioequivalence Issues | Isadore Kanfer (u. a.) | Buch | Einband - fest (Hardcover) | Englisch | 2007 | CRC Press | EAN 9780849377846 | Verantwortliche Person für die EU: Libri GmbH, Europaallee 1, 36244 Bad Hersfeld, gpsr[at]libri[dot]de | Anbieter: preigu Print on Demand.…