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Global Regulators Zero In On Pediatric Extrapolation To Speed Up Drug Access

 
• By Neena Brizmohun

Newly published guidance that for the time first details how to use pediatric extrapolation and aims to decrease variations in regulatory expectations globally is now ready for implementation around the world.

A new guidance is designed to facilitate more timely access to pediatric medicines globally • Source: Shutterstock

Similarity of disease, drug pharmacology, and response to treatment between a reference and pediatric target population.

These are among the many topics covered in E11A, the guidance dedicated to how to use extrapolation to support pediatric drug development that the International Council for Harmonisation (ICH) has...

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