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

Summary

Study Overview

The Objective of This Benchmarking Study Was to Better Understand Fixed-Dose Combination (Containing Two or More Active Pharmaceutical Ingredients) Product Development Strategies and Timelines. The Research Explored A Number of Critical Questions, Including: Whether Organizations Seek Additive or Synergistic Fdc Drugs; Why Companies Chose Either A Bioequivalence or Clinical Evaluation Approach; and Whether Organizations Are Using External Consultants and Why. among The Many Benchmarks Included in This Study Are Timeframes for Both Bioequivalence and Clinical Evaluation Development Approaches and The Number, Types and Frequency of Tests Required. Executives Who Are Responsible for Fixed-Dose Combination (Fdc) Drug Development Can Use This Data to Assess The Effectiveness and Efficiency of Their Fdc Drug Product Development Programs.

Key Topics

• Bioequivalence Approach
• Clinical Evaluation Approach
• Lessons Learned
• Ftes and Complexity

Methodology

This Research Was Conducted on Behalf of One of Best Practices, Llc's Clients and Was Based on Survey Results from 15 Participants from 11 Companies. This Study Gives Companies A Landscape View of How Other Organizations Are Pursuing Fdc Drug Development.

Industries Profiled

Pharmaceutical; Consumer Products; Diagnostic; Health Care; Biotechnology

Companies Profiled

Abbott Laboratories; Supernus; Bausch & Lomb; Bayer; Hoffman-Laroche; Merck; Pfizer; Sanofi-Aventis; Solvay Pharmaceuticals; Takeda Pharmaceuticals; Ucb Pharma

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
  • Ivitro Work
  • Animal Pharmacokinetic Studies
  • Human Pharmacokinetic Studies
  • Prototype Optimization
  • Effective Development Strategies
• Phase 1: Clinical Evaluation Approach
  • Prototype Completion
  • Ivitro Work
  • Steps Necessary to Move Forward to Clinical Trials
  • Ivivo 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