Drug products for clinical trials

著者

    • Monkhouse, Donald C.
    • Carney, Charles (Charles F.)
    • Clark, Jim

書誌事項

Drug products for clinical trials

edited by Donald C. Monkhouse, Charles F. Carney, James L. Clark

(Drugs and the pharmaceutical sciences, v. 147)

Taylor & Francis, 2006

2nd ed

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注記

Includes bibliographical references and index

内容説明・目次

内容説明

Addressing issues at the forefront of interest for the Clinical Trial Materials Professional (CTMP), this Second Edition highlights the most critical concepts related to the planning, manufacturing, packaging, labeling, distribution, reconciliation, and quality and regulatory control of clinical trial materials-offering an authoritative selection of chapters on the current and evolving state of clinical supplies operations by esteemed researchers and consultants in industry.

目次

The Importance of Clinical Trials. QA Global Perspective. Special Facilities. Robotics. Execution Systems. Blinding. IVRS. Contracting and Outsourcing. Training. Devices. Inhalation Systems. Overseas Trials. A Comparison of Global Regulations. Packaging Compliance. Project Management

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