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Showing 1 - 12 of 12 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

    $94.99 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

    $67.99 USD

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  • Principles and Practice of Clinical Research

    Edited by Frederick P Ognibene, John I. Gallin ...
    The third edition of this innovative work again provides a unique perspective on the clinical discovery process by providing input from experts within the NIH on the principles and practice of clinical research. Molecular medicine, genomics, and proteomics have opened vast opportunities for translation of basic science observations to the bedside through clinical research. As an introductory ... Read more

    $112.49 USD

  • Early Drug Development

    Strategies and Routes to First-in-Human Trials

    Edited by Mitchell N. Cayen ...
    The focus of early drug development has been the submission of an Investigational New Drug application to regulatory agencies. Early Drug Development: Strategies and Routes to First-in-Human Trials guides drug development organizations in preparing and submitting an Investigational New Drug (IND) application. By explaining the nuts and bolts of preclinical development activities and their ... Read more

    $161.00 USD

  • Global New Drug Development

    An Introduction

    by Jan A. Rosier, Mark A. Martens, Josse R. Thomas ...
    Series series ULLA Series in Pharmaceutical Sciences
    The development of new drugs is very complex, costly and risky. Its success is highly dependent on an intense collaboration and interaction between many departments within the drug development organization, external investigators and service providers, in constant dialogue with regulatory authorities, payers, academic experts, clinicians and patient organizations. Within the different phases of ... Read more

    $110.00 USD

  • Fast Facts: Biosimilars in Hematology and Oncology

    Biologics and biosimilars - getting decisions right

    by Paul Cornes, Ali McBride ...
    Biologics have revolutionized – and are revolutionizing – the treatment of many serious disorders. The evidence acquired from more than 10 years of clinical experience, with more than 50 biosimilar drugs and more than 700 million patient-days' exposure in Europe, shows that approved biosimilars can be used as safely and effectively as originator biologics. Yet concerns persist about biosimilars – ... Read more

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  • A Clinical Trials Manual From The Duke Clinical Research Institute

    Lessons from a Horse Named Jim

    by Margaret Liu, Kate Davis ...
    "The publication of the second edition of this manual comes at an important juncture in the history of clinical research. As advances in information technology make it possible to link individuals and groups in diverse locations in jointly seeking the answers to pressing global health problems, it is critically important to remain vigilant about moral and ethical safeguards for every patient ... Read more

    $80.00 USD

  • Principles and Practice of Pharmaceutical Medicine

    Edited by Lionel D. Edwards, Anthony W. Fox, Peter D. Stonier ...
    The new edition of Principles and Practice of Pharmaceutical Medicine is a comprehensive reference guide to all aspects of pharmaceutical medicine. New content includes chapters and coverage on regulatory updates, increasing international harmonization, transitional and probabilistic approaches to drug development, the growing sophistication and regulatory importance of pharmacovigilance, ... Read more

    $300.00 USD