Application of a Stochastic Simulation-estimation Approach to Optimize Pharmacokinetic Study Design in the Context of Paediatric Extrapolation: A Tool to Support Decision-making by Drug Sponsors and Regulators
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Background: Extrapolation-based approaches are widely used in paediatric drug development. These often rely on pharmacokinetic (PK) matching to support inference on the benefit-risk balance (BRB). PK-based extrapolation requires ... ...
