Monkhouse / Carney / Clark Drug Products for Clinical Trials, Second Edition

2. Auflage 2005
ISBN: 978-0-8493-5276-8
Verlag: Taylor & Francis
Format: PDF
Kopierschutz: Adobe DRM (»Systemvoraussetzungen)

E-Book, Englisch, 432 Seiten

Reihe: Drugs and the Pharmaceutical Sciences

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.

Zielgruppe

Clinical trial materials professionals, clinical coordinators, clinical monitors, government drug regulatory personnel, pharmaceutical development and research personnel, pharmacologists, pharmacists, and clinical chemists.

Autoren/Hrsg.

Monkhouse, Donald

Carney, Charles F.

Clark, Jim

Brun, Peter

Fachgebiete

• Technische Wissenschaften Verfahrenstechnik | Chemieingenieurwesen | Biotechnologie Pharmazeutische Technologie
• Wirtschaftswissenschaften Wirtschaftssektoren & Branchen Fertigungsindustrie Pharmaindustrie

Inhaltsverzeichnis

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