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並前往https://www.aphis.usda.gov/animal_health/vet_biologics/publications/OverviewPotencyPolicy.pdf

Overview of Potency Assay Policy Development - USDA APHIS

ICH Q1A(R2), ICH Q1E, VICH GL3(R), VICH GL51; FDA Guidance for Industry: Content and Format of Chemistry, Manufacturing and.

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