Drug Products for Clinical Trials highlights the most critical concepts related to the planning, manufacturing, packaging, labeling, distribution, reconciliation, and quality and regulatory control of clinical trial materials.

Features:

• Helps the CTMP operate effectively in the international sphere and reviews regulatory processes for drug approvals in the United States and Europe
• Discusses the role of the CTMP in the shepherding of a new medicament from inception to market
• Highlights the need for CTMPs to acquire contemporary knowledge of the rapidly evolving clinical trial process
• Provides a chapter on facilities design and utilization for the production of potent and hazardous products-describing a classification system for potent compounds and containment practices for all manufacturing scales
• Covers the manufacturing and control practices necessary to produce blinded products-treating all varieties of dosage forms such as solids, liquids, injectable products, creams, and ointments
• Offers a complete survey of inhalation products-including preformulation and formulation concerns and comparisons of various inhalation products
• Includes step-by-step discussion of packaging and labeling protocols
• Presents systematic approaches to define and develop working agreements for the most effective return of deliverables form outsourced work

Contents

• 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

Index

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