Drug Products for Clinical Trials

ISBN-13: 9780824754624 / Angielski / Twarda / 2005 / 432 str.

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

Opis

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. It offers authoritative chapters by esteemed researchers and consultants in industry on the current and evolving state of clinical supplies operations. Tracking emerging trends and the development of new technologies, this Second Edition helps the CTMP operate effectively in the international sphere and reviews regulatory processes for drug approvals in the United States and Europe.

Spis treści

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

O autorze

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