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New Study Shares Benchmarks for Fixed-Dose Combination (FDC) Drug Development
Date:2/5/2009

d 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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