title: Pharmacometrics for regulatory decision making: status and perspective.
authors: European Medicines Agency (EMA), London, UK.
authors: Efthymios
authors: E
authors: Manolis
authors: Ralf
authors: R
authors: Herold
mesh_terms: D003661:Decision Support Techniques; D004348:Drug Labeling / Q000592:standards* / Q000706:statistics & numerical data*; D006801:Humans; D017387:Investigational New Drug Application / Q000706:statistics & numerical data*