© 2006 – CRC Press
432 pages | 39 B/W Illus.
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.
"This practical guide…offer[s] authoritative evaluations of the scientific & legal issues involved in the successful completion of clinical trials for marketing approval by regulatory agencies."
-Unlisted Drugs (for previous edition)
"…very comprehensive on the subject and give[s] a lot of "how-to" information….
"…very well written and very much geared towards the US market and Food and Drug Administration requirements."
-European Journal of Parenteral Sciences (for previous edition)
"…describes both the science and the management of product development and furnishes effective approaches for preclinical drug discovery."
-BOOKNews on the Internet (for previous edition)
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