-- 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 report, contact Robert Naylor at rnaylor@best-in-class.com or (919) 767-9244. To access the full report or download a complimentary copy of the report summary, go to http://www3.best-in-class.com/rr973.htm .
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