Drug Products for Clinical Trials
Editat de Donald Monkhouse, Charles F. Carney, Jim Clark, Peter Brunen Limba Engleză Hardback – 9 noi 2005
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Specificații
ISBN-13: 9780824754624
ISBN-10: 082475462X
Pagini: 432
Ilustrații: 39 b/w images, 13 tables and 1 halftone
Dimensiuni: 152 x 229 x 25 mm
Greutate: 0.68 kg
Ediția:2Revizuită
Editura: CRC Press
Colecția CRC Press
ISBN-10: 082475462X
Pagini: 432
Ilustrații: 39 b/w images, 13 tables and 1 halftone
Dimensiuni: 152 x 229 x 25 mm
Greutate: 0.68 kg
Ediția:2Revizuită
Editura: CRC Press
Colecția CRC Press
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Public țintă
Academic and Professional Practice & DevelopmentCuprins
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
Notă biografică
Donald C. Monkhouse, Charles F. Carney, James L. Clark
Descriere
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.