New Study Provides Benchmarks for Fixed-Dose Combination (FDC) Drug Development

Wednesday, November 5, 2008 General News J E 4
CHAPEL HILL, N.C., Nov. 4 As biopharmaceutical companiesfocus on line extensions and new product development opportunities, fixed-dosecombination (FDC) products have become an increasingly important segment ofthe market. In an effort to better understand the development strategies andissues for new FDC products, a recent study was conducted by Best Practices,LLC, with insights available in the newly published report, "ProductCommercialization Excellence: Preparation and Management of Fixed-doseCombination (FDC) Drug Products." The research explored a number of criticalquestions, including: whether organizations seek additive or synergistic FDCdrugs; why companies chose either a bioequivalence or clinical evaluationapproach; and whether organizations are using external consultants and forwhat purposes.

Among the many benchmarks included in this study are timeframes for bothbioequivalence and clinical evaluation development approaches and the number,types and frequency of tests required. Executives who are responsible forfixed-dose combination (FDC) drug development can use this data to assess theeffectiveness 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 ofFixed-dose Combination (FDC) Drug Products," click on the following link .

In a benchmarking study that included such influential companies asAbbott, Bayer, Roche, Merck, Pfizer, and Sanofi-Aventis, many key topics werecovered, including:

For more information on this report, contact Robert Naylor or (919) 767-9244. To access the full report ordownload a complimentary copy of the report summary, go to .


Best Practices, LLC, conducts work based on the simple yet profoundprinciple that organizations can chart a course to superior economicperformance by studying the best business practices, operating tactics andwinning strategies of world-class companies. For more than 15 years, ourhighly credentialed research staff has conducted primary research exclusivelyfor our Fortune 500 client base.-- 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 Launch -- Bioequivalence - 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

SOURCE Best Practices, LLC


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