Best Practice Database Provides Benchmarks for Fixed-Dose Combination (FDC) Drug D... (tudy abstract or complimentary summary o...)

Best Practice Database Provides Benchmarks for Fixed-Dose Combination (FDC) Drug Development

Date:11/13/2008

tudy 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/dr337.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

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

For more information on this study or the Best Practice Database, contact Robert Naylor at rnaylor@best-in-class.com or (919) 767-9244. Interested parties may sign-up for a customized tour of the database via the followi
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