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並前往https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-strategies-identify-mitigate-risks-first-human-early-clinical-trials-investigational_en.pdf

Guideline on strategies to identify and mitigate risks for first-in

Guideline on strategies to identify and mitigate risks for first-in-human and early clinical trials with investigational medicinal products.

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