Current Use of Physiologically Based Pharmacokinetic modeling in New Medicinal Product Approvals at EMA.

A retrospective study that evaluated the use of PBPK models in submissions to the EMA prior to the 2018 guideline showed an increasing trend in their use over the period 2004–2015 inclusive. 8 The submitted models were used to predict specific aspects of the pharmacokinetics of a drug candidate, from drug–drug interactions (DDIs) to absorption and bioavailability to pharmacokinetics in special populations.

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