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Model-Informed Drug Development: A Risk Firms, Regulators Need To Embrace

 
• By Sue Sutter

Modeling can better inform candidate and dose selection, and support novel endpoints, labeling and postmarketing safety, even though it means stepping off the beaten path for drug development, participants say at US FDA's inaugural workshop on model-informed drug development under PDUFA VI.

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Using modeling in drug development still requires a leap of faith.

Increased use of modeling in drug development could better inform candidate selection, optimize dose selection, and support novel endpoints, labeling and postmarketing safety.

However, regulators, sponsors and the clinical community will have to take the risk of stepping away from the well-trodden path of drug development if they are going to embrace modeling...

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