Dutch Medicines Evaluation Board Reports Findings in Drug Research (A review on the role of extrapolation as basis for paediatric marketing authorization applications of medicines in the EU).

A recent study conducted by the Dutch Medicines Evaluation Board in Utrecht, Netherlands, examined the role of extrapolation in pediatric marketing authorization applications for medicines in the EU. The research found that applications supported by extrapolation based on exposure-matching were more successful in obtaining approval for the targeted pediatric population, but were less efficient in terms of drug development duration. This study highlights the importance of evidence-based strategies in regulatory approval processes for pediatric medications. [Extracted from the article]