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ICH Expansion To Bring New Challenges For Global Consensus On Pediatric Extrapolation

 
• By Vibha Sharma

The pharmaceutical industry is cautiously optimistic about the ambitious three-year timeline decided by the International Council for Harmonisation for its new guideline on pediatric extrapolation. However, ensuring consensus on this fast-developing concept will be a challenge as more regulators will have a seat at the discussion table as ICH expands.

Extrapolation
ICH Working Group On Pediatric Extrapolation Will Meet In Geneva In November • Source: Shutterstock

Work on the first ever detailed international guideline on pediatric extrapolation is due to begin shortly, but achieving consensus on this much-debated topic will not be an easy task for the International Council for Harmonisation, which is expanding its membership with the result that more regulators are expected to join the discussion, AstraZeneca's Solange Corriol-Rohou told a conference in London last week.

The topic of pediatric extrapolation was briefly touched upon in a recently finalized ICH guideline - E11(R1), which is an addendum to the ICH's existing 17-year-old guideline on the clinical investigation of medicinal products in the pediatric population

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