Modeling and Simulation Support for Pediatric Drug Development

Daniel Röshammar, Martin Bergstrand and Moustafa Ibrahim, of Pharmetheus are co-authors to the publication ‘Pharmacokinetic Modeling and Simulation Support for Age‐ and Weight‐Adjusted Dosing of Dabigatran Etexilate in Children with Venous Thromboembolism (VTE)’, accepted in the Journal of Thrombosis and Haemostasis. It describes the recommended dabigatran etexilate (Pradaxa®) dosing schedule (capsules, coated granules in sachets and oral solution) for the treatment and prevention of VTE in this pediatric population (from birth to less than 18 years of age). The model-based dosing strategy led by Boehringer Ingelheim and Pharmetheus as partners was submitted to EMA and recently received EU marketing authorization. The publication provides one example of Pharmetheus’ experience with pediatric drug development and how a suitable dose in children can be derived by using a model-based approach to leverage information from both children and adults. 

Read the publication here.