Development and Approval of Combination Products guides you step by step through all the preclinical, clinical, and manufacturing stages.

Development and Approval of Combination Products includes:

• The pharmacology, safety pharmacology, and toxicology supporting human clinical trials of combination products
• Approaches to clinical trial protocol design and execution
• Chemical, physicochemical, and analytical aspects of manufacturing controls and validation that lead to stable components for combination products
• Key sponsor/FDA meetings and negotiations essential for approval and commercialization

Contents

Overview of Combination Products Development and Regulatory Review

Detailed Regulatory Approaches to Development, Review, and Approval

• General Background
• Combination Products: Regulatory Background
• Postmarketing Considerations

Nonclinical Recommendations for Successful Characterization and Development of Combination Drug Products

• Pharmacology
• Pharmacokinetics
• Toxicology

Clinical Pharmacology and Clinical Development of Combination Products

• Postapproval Clinical Safety Reporting
• Clinical Development of Drug–Delivery System Combination Products
• Clinical Development of Drug–Active Device Combination Products
• Clinical Development of Co-Packaged Combination Products
• Clinical Development of Drug–In Vitro Diagnostic Combination Products
• Clinical Development of Drug–Biologic Combination Products
• Clinical Development of Drug–Drug Combinations

Regulatory Strategy Considerations for Chemistry, Manufacturing, and Controls: An Integrated Approach

• Office of Combination Products (OCP) and Request for Designation (RFD)
• Extent of Regulatory Oversight
• Investigational Device Exemption and Investigational New Drug Exemption
• Regulatory Compliant Product Development
• Chemistry, Manufacturing, and Controls Review Requirements
• Drug Component Requirements
• Device Component Requirements
• Sterilization Considerations
• Stability Considerations
• Bench Testing and Early Development Considerations
• CDP Regulatory Cross-Mapping Guidance and Recommendations

Index

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