Guideline Similar Biological Medicinal Products Containing Biotechnology Derived Proteins Active Substance Quality Issues Revision 1
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/guideline-similar-biological-medicinal-products-containing-biotechnology-derived-proteins-active-substance-quality-issues-revision-1
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