Product Commercialization Excellence: Preparation and Management of Fixed-Dose Combination Drug Products

Table of Contents

STUDY OVERVIEW

• Research Objective & Methodology
• Benchmark Class
• Participant Qualification
• Definitions
• Data Interpretation
• Increasing Number of FDC Drugs Planned in the Future
• Both Additive and Synergistic Effects Sought
• Development Approaches: Bioequivalence vs. Clinical Evaluation
• Development Strategy
• Patent Expiration
• External Consultants
• Bioequivalence
• Clinical Evaluation

PHASE 1: BIOEQUIVALENCE APPROACH

• Great Variation in Timeframe for Prototype Completion
• In-Vitro Work
• Animal Pharmacokinetic Studies
• Human Pharmacokinetic Studies
• Prototype Optimization
• Effective Development Strategies

PHASE 1: CLINICAL EVALUATION APPROACH

• Prototype Completion
• In-Vitro Work
• Steps Necessary to Move Forward to Clinical Trials
• In-Vivo Work
• Prototype Optimization
• Effectiveness

PHASE 1: LESSONS LEARNED

• FDC Development

PHASE 2: FTES AND COMPLEXITY

• Pilot Pharmacokinetic Studies
• Number of Drugs Evaluated at First Pilot PK Study
• Number of Drugs Evaluated at Second Pilot PK Study
• Number of Drugs Evaluated at Pivotal BE Study
• Average FTEs at First Pilot PK Study
• Average FTEs at Second Pilot PK Study
• Average FTEs at Pivotal BE Study
• Timeframe Required to Reach First Pilot PK Study
• Timeframe Required to Reach Second Pilot PK Study
• Timeframe Required to Reach Pivotal BE Study
• Number of FTEs Involved in Analytical Development
• Timeframe between Formulation and CTM Manufacturing

ABOUT BEST PRACTICES, LLC