New Study Provides Benchmarks for Fixed-Dose Combination (FDC) Drug Development
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 linkhttp://www3.best-in-class.com/rr973.htm .
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 firstname.lastname@example.org or (919) 767-9244. To access the full report ordownload a complimentary copy of the report summary, go tohttp://www3.best-in-class.com/rr973.htm .
ABOUT BEST PRACTICES, LLC
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
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