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Drug Products for Clinical Trials de Donald Monkhouse

Drug Products for Clinical Trials

Editat de Donald Monkhouse, Charles F. Carney, Jim Clark, Peter Brun
en Limba Engleză Paperback – 19 sep 2019
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.
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Specificații

ISBN-13: 9780367391799
ISBN-10: 0367391791
Pagini: 432
Dimensiuni: 152 x 229 x 23 mm
Greutate: 0.45 kg
Ediția:2nd edition
Editura: CRC Press
Colecția CRC Press

Public țintă

Academic and Professional Practice & Development

Cuprins

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.