ICH Harmonised Guideline Nonclinical Safety Testing Support Development Paediatric Pharmaceuticals
TGA (CWLTH) resource. Rules Mate indexes this as part of the Australian compliance corpus. Click through for the regulator's primary source.
https://www.tga.gov.au/resources/resources/international-scientific-guidelines-adopted-australia/ich-harmonised-guideline-nonclinical-safety-testing-support-development-paediatric-pharmaceuticals
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