Policy statement: Use of pharmacometrics in drug submissions and clinical trial applications

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Pharmacometrics is the science of using quantitative analysis and modelling and simulation (M&S) approaches to inform and enhance drug development and regulatory review. Pharmacometrics also encompasses quantitative system pharmacology and model-informed drug development (MIDD) approaches.

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Name Format Description Link
Policy statement: Use of pharmacometrics in drug submissions and clinical trial applications HTML Open resource
Policy statement: Use of pharmacometrics in drug submissions and clinical trial applications HTML Open resource

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