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  • 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...

  • Generic Drug Product Developmentby Isadore Kanfer; Leon Shargel

    CRC Press 2007; US$ 157.95

    Introduction - Bioequivalence Issues. Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book). Pharmaceutical Alternatives: Considerations for Generic Substitution. Pharmacodynamic Measurements for Determination of Bioequivalence. Bioequivalence Using Clinical Endpoint Studies. Evaluation of Bioequivalence of Highly-Variable... more...

  • Generic Drug Product Developmentby Leon Shargel; Isadore Kanfer

    CRC Press 2010; US$ 167.95

    Introduction, Leon Shargel Nonsystemically Absorbed Oral Drug Products, Marc Lefebvre Topical Drug Products?Development, Manufacture and Regulatory Issues, Mary Beth G. Erstad and Candis Edwards Assessment of Topical Dosage Forms Intended for Local or Regional Activity, Isadore Kanfer, Ralph Nii Okai Tettey-Amlalo, Wai Ling Au, and Betsy Hughes-Formella... more...

  • Generic Drug Product Developmentby Isadore Kanfer; Leon Shargel

    CRC Press 2010; US$ 167.95

    Introduction Isadore Kanfer Australasia C. T.Hung, D. Ren, L. A. Folland, F. C. Lam, Noelyn AnneHung, and R. Smart Brazil Margareth R. C. Marques, S?lvia Storpirtis, and Marcia Martini Bueno Canada Iain J. McGilveray The European Union Roger K. Verbeeck and Joelle Warlin India Subhash C. Mandal and S. Ravisankar Japan Juichi Riku South... 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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