ICH E11A Pediatric Extrapolation

Titel:

Internet:

https://www.gmp-navigator.com/files/guidemgr/E11A_EWG_Concept_Paper (2).pdf

Herkunft/Verlag:

ICH

Dokumentenart:

Concept Paper

Inhalt:

This new ICH Guideline is proposed for harmonisation of methodologies and strategies to incorporate paediatric extrapolation into overall drug development plans and therefore improve the speed of access to new drugs for paediatric patients while limiting the number of children required for enrolment in clinical trials.

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