ICH Agrees On New Extrapolation Guideline To Support Pediatric Development
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.
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A new document that complements the International Council for Harmonisation's existing guideline on pediatric clinical trials is expected to reduce the likelihood of significant differences among countries on the acceptance of data generated in pediatric global drug development programs
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