ICH M9 Guideline Biopharmaceutics Classification System Based Biowaivers
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-m9-guideline-biopharmaceutics-classification-system-based-biowaivers
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