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Regulatory Focus™ > News Articles > SCIENCE & TECHNOLOGY Maximizing the Value of Early Phase Drug Development

SCIENCE & TECHNOLOGY Maximizing the Value of Early Phase Drug Development

Posted 01 March 2011

In the current environment of increasingly rigorous regulatory requirements and tightening fiscal constraints, it is more critical than ever for sponsors to optimize selection of new drug candidates and develop them effectively. Early phase clinical studies provide pivotal decision points that support selection of the right candidate and the right dose to maximize success during the dollar-hungry Phase 3 program. A mistake in early phase development could escalate to a costly failure of the Phase 3 program. According to current estimates, over 55% of drugs fail while in Phase 2 and over 36% fail while in Phase 3 development.

 

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