Drug Products for Clinical Trials  book cover
2nd Edition

Drug Products for Clinical Trials

ISBN 9780367391799
Published September 19, 2019 by CRC Press
432 Pages

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Book Description

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.

Table of Contents

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