As biopharmaceutical companies focus on line extensions and new product development opportunities, fixed-dose combination (FDC) products have become an increasingly important segment of the market.

In an effort to better understand the development strategies and issues for new FDC products, a recent study was conducted by Best Practices, LLC, with insights available in the newly published report, “Product Commercialization Excellence: Preparation and Management of Fixed-dose Combination (FDC) Drug Products.” 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 for what purposes.

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.

To view the study abstract or complimentary summary of the full report “Product Commercialization Excellence: Preparation and Management of Fixed-dose Combination (FDC) Drug Products,” click on the following link http://www3.best-in-class.com/re938.htm .

In a benchmarking study that included such influential companies as Abbott, Bayer, Roche, Merck, Pfizer, and Sanofi-Aventis, many key topics were covered, including:

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

Among the key metrics gathered in this report are:

  • Past, Present and Future Number of FDC Drugs in Development
  • Additive vs. Synergistic Effects
  • Bioequivalence vs. Clinical Evaluation (Preferences and reasons why)
  • Starting Development Prior vs. Post Patent Expiration
  • Use of External Consultants
  • Bioequivalence — Timeframe from Conception to Final Formulation Launch
  • Clinical Evaluation — Timeframe from Conception to Final Formulation LaunchBioequivalence — Timeframe from Initiating Formulation Development to Final Formulation Launch
  • Clinical Evaluation — Timeframe from Initiating Formulation Development to Final Formulation Launch
  • Bioequivalence — Multiple Metrics
  • Clinical Evaluation — Multiple Metrics
  • Number of Drugs, FTEs and Timeframe to Reach First/Second Pilot PK Study
  • Number of Drugs, FTEs and Timeframe to Reach Pivotal BE Study
  • Number of FTEs in Analytical Development
  • Timeframe from Initiating Development Work to CTM Manufacturing for Class 1/2/4 drugs

To access a full copy of the report or download a free excerpt, click the following link: http://www3.best-in-class.com/re938.htm .

Source: Best Practices, LLC




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