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Showing 1 - 6 of 6 results for “isadore kanfer”
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  • Generic Drug Product Development

    Bioequivalence Issues

    by Isadore Kanfer, Leon Shargel ...
    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 comp ... Read more

    $245.00 USD

  • Generic Drug Product Development

    Specialty Dosage Forms

    by Leon Shargel, Isadore Kanfer ...
    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 dru ... Read more

    $89.99 USD

  • Bioequivalence Requirements in Various Global Jurisdictions

    Edited by Isadore Kanfer ...
    Series series Chemistry and Material Science (R0)
    An important objective of Bioequivalence Requirements in Various Global Jurisdictions is to attempt to gather current and updated information, collated in a single source, regarding the various bioequivalence and related requirements to satisfy the regulatory requirements for the market approval of multi-source (generic) drug products in various global jurisdictions.In view of the dynamic nature ... Read more

    $188.09 USD

  • Bioequivalence Requirements in Various Global Jurisdictions

    Edited by Isadore Kanfer ...
    Series series Biomedical and Life Sciences (R0)
    Although the Bioequivalence (BE) requirements in many global jurisdictions have much in common, differences in certain approaches and requirements such as definitions and terms, choice of comparator (reference) product, acceptance criteria, fasted and fed studies, single and multi-dose studies, biowaivers and products not intended for absorption into the systemic circulation (locally acting ... Read more

    $215.09 USD

  • Generic Drug Product Development

    International Regulatory Requirements for Bioequivalence

    Edited by Isadore Kanfer, Leon Shargel ...
    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 therapeutica ... Read more

    $89.99 USD

  • Generic Drug Product Development

    Solid Oral Dosage Forms, Second Edition

    Edited by Leon Shargel, Isadore Kanfer ...
    Series series Drugs and the Pharmaceutical Sciences
    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 ... Read more

    $64.99 USD