ICH Topic Q 5 E Comparability Biotechnological Biological Products
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-topic-q-5-e-comparability-biotechnological-biological-products
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