1st Edition

Clinical Development Strategic, Pre-Clinical, and Regulatory Issues

By Janice Steiner Copyright 1996
    248 Pages
    by CRC Press

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    Everyone involved in pre-clinical, clinical, formulation, development and regulatory affairs will find Clinical Development a valuable resource. The book provides expert advice on ways to reduce delays and lost market opportunities, minimize development time, better understand the process and regulatory requirements, and plan and analyze clinical development and testing programs. The author combines text, graphs, and charts to show how a company moves a product through the complex process from discovery to market. The result is a complete analysis of the drug development process in easy-to-understand language and easy-to-implement action steps.

    o Developing a complete strategy
    o Analyzing potential markets in depth
    o Preparing the clinical plan
    o Understanding the pre-clinical requirements
    o Incorporating regulatory plans early in the process
    o Meeting Good Clinical Practice (GCP) regulations
    o Managing the project plan
    o Mastering the process - a detailed case study


    Steiner\, Janice