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Stop Costly Phase III Failures

By Murray P. Ducharme, PharmD, FCCP, FCP; Philippe Colucci, MSc; and Corinne Seng Yue, BPharm, MSc

More efficient drug development through modeling and simulations can save you time and money.

In the world of drug development, there is definitely a move causing sponsors to look more closely at the early phase of a drug’s development to help ascertain their investments.

High failure rates are most often related to safety and efficacy outcomes at the end of the drug development process. It is estimated that in recent years, approximately 30% of all failures are related to a lack of efficacy; another 30% of failures are attributable to toxicity.

Through industry-accepted modeling and simulation techniques, research has found that an increased percentage of costly phase III failures could have been prevented in the early phases of development.

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