FDAnews Drug Daily Bulletin

EMA Seeks Comments on its PK Guideline for Pediatric Drug Development

May 12, 2017

The European Medicines Agency is planning to revise its guideline on the role of pharmacokinetics in pediatric drug development and is inviting public comment.

The revised guideline will focus mainly on study design, including the role of PK and pharmacodynamics in dose finding, exposure-response modeling data, formulations, and how best to extrapolate data from adult populations.

The revision will also cover in-trial dosage adaptations, study acceptance criteria, and simulation-based approaches, along with recommendations for data analysis, modeling and presentation.

The EMA concept paper is open to public comment through July 31.

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