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  • Generic Drug Product Developmentby Isadore Kanfer; Leon Shargel

    CRC Press 2007; US$ 157.95

    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... more...

  • Generic Drug Product Developmentby Leon Shargel; Isadore Kanfer

    CRC Press 2010; US$ 167.95

    Generic Drug Product Development: Specialty Dosage Forms explores the issues related to providing evidence of pharmaceutical equivalence and bioequivalence for specialty drug products. It describes various scientific approaches and regulatory requirements for manufacturers who need to demonstrate the therapeutic equivalence of generic specialty... more...

  • Generic Drug Product Developmentby Isadore Kanfer; Leon Shargel

    CRC Press 2010; US$ 167.95

    Due to a worldwide need for lower cost drug therapy, use of generic and multi-source drug products have been increasing. To meet international patent and trade agreements, the development and sale of these products must conform to national and international laws, and generic products must prove that they are of the same quality and are therapeutically... more...

  • Generic Drug Product Developmentby Leon Shargel; Isadore Kanfer

    CRC Press 2013; US$ 209.95

    In this era of increased pharmaceutical industry competition, success for generic drug companies is dependent on their ability to manufacture therapeutic-equivalent drug products in an economical and timely manner, while also being cognizant of patent infringement and other legal and regulatory concerns. Generic Drug Product Development: Solid Oral... more...

  • Applied Biopharmaceutics & Pharmacokinetics, Seventh Editionby Leon Shargel; Andrew Yu

    McGraw-Hill Education 2015; US$ 75.00

    The landmark textbook on the theoretical and practical applications of biopharmaceutics and pharmacokinetics?now fully updated. Explains how to detect clinical pharmacokinetic problems and apply basic pharmacokinetic principles to solve them Helps you critically evaluate biopharmaceutic studies involving drug product equivalency and unequivalency... more...

  • Applied Biopharmaceutics & Pharmacokinetics, Sixth Editionby Leon Shargel; Andrew Yu; Susanna Wu-Pong

    McGraw-Hill Education 2012; US$ 85.00

    A comprehensive textbook on the theoretical and practical applications of biopharmaceutics and pharmacokinetics The field?s leading text for more than three decades Applied Biopharmaceutics & Pharmacokinetics, Sixth Edition provides you with a basic understanding of the principles of biopharmaceutics and pharmacokinetics and applies... more...

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