美国FDA 指导原则 单位剂量分装固体口服剂型药品保质期工业指南 英文原版.pdfVIP

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美国FDA 指导原则 单位剂量分装固体口服剂型药品保质期工业指南 英文原版.pdf

Expiration Dating of Unit-Dose Repackaged Solid Oral Dosage Form Drug Products Guidance for Industry U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) July 2020 Pharmaceutical Quality/Manufacturing Standards (CGMP) Expiration Dating of Unit-Dose Repackaged Solid Oral Dosage Form Drug Products Guidance for Industry

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