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並前往https://www.fda.gov/files/drugs/published/Bioanalytical-Method-Validation-Guidance-for-Industry.pdf

Bioanalytical Method Validation - Guidance for Industry | FDA

Bioanalytical Method Validation. 05/24/18. Bioanalytical Method. Validation. Guidance for Industry. U.S. Department of Health and Human Services.

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