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ICH Agrees On New Extrapolation Guideline To Support Pediatric Development

 
• By Vibha Sharma

The International Council for Harmonisation took several key decisions at it latest meeting in Canada, such as developing a new dedicated guideline on extrapolation, admitting a group representing the world's leading pharmaceutical inspectorates as an observer, and adopting revised rules and procedures to ensure the ICH remains ‘agile’ as it grows.

Extrapolation
ICH To Develop New Detailed Guidance On Extrapolation For Pediatrics • Source: Shutterstock

The International Council for Harmonisation (ICH) has agreed to develop a new harmonized guideline on extrapolation to support the development of pediatric medicines. The new guideline, which is being developed in response to suggestions made by the industry, will go beyond the current high-level advice on extrapolation that is already available in a draft ICH guideline on clinical investigation of pediatric medicines.

The need for a detailed extrapolation guideline was agreed at the ICH’s meeting in Montreal, Canada, on May 27 to...

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