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並前往https://www.ema.europa.eu/en/documents/scientific-guideline/ich-topic-q-5-c-quality-biotechnological-products-stability-testing-biotechnological/biological-products_en.pdf

ICH Topic Q 5 C Quality of Biotechnological Products: Stability ...

The guidance stated in the ICH Harmonised Tripartite Guideline 'Stability Testing of New. Drug Substances and Products' (27 October 1993) applies in general to.

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