Búsqueda de LIBROS DEL AUTOR: brody tom

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  • FDA'S DRUG REVIEW PROCESS AND THE PACKAGE LABEL
    ebook
    FDA'S DRUG REVIEW PROCESS AND THE PACKAGE LABEL
    TOM BRODY
    FDA's Drug Review Process and the Package Label provides guidance to pharmaceutical companies for writing FDA-submissions, such as the NDA, BLA, Clinical Study Reports, and Investigator's Brochures. The book provides guidance to medical writers for drafting FDA-submissions in a way more likely to persuade FDA reviewers to grant approval of the drug. In detail, the book reproduc...

    $1,994.00

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  • CLINICAL TRIALS: STUDY DESIGN, ENDPOINTS AND BIOMARKERS, DRUG SAFETY, AND FDA AND ICH GUIDELINES
    ebook
    CLINICAL TRIALS: STUDY DESIGN, ENDPOINTS AND BIOMARKERS, DRUG SAFETY, AND FDA AND ICH GUIDELINES
    BRODY, TOM
    Clinical Trials, Second Edition, offers those engaged in clinical trial design a valuable and practical guide. This book takes an integrated approach to incorporate biomedical science, laboratory data of human study, endpoint specification, legal and regulatory aspects and much more with the fundamentals of clinical trial design. It provides an overview of the design options al...

    $1,329.00

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