審查觀點及法規文章
- 1 當代醫藥月刊: COVID-19 mRNA疫苗之化學製造管制法規研究
- 2 醫藥品查驗中心: 脂質奈米粒包覆mRNA疫苗類型產品 ─ 於CMC放行規格檢測項目與適合的分析方法考量
- 3 醫藥品查驗中心: 細胞治療製劑製程中使用自動化系統之法規科學
- 4 醫藥品查驗中心: 藥品可浸出物及可滲出物之研發策略指導原則
- 5 ICH Q13 CONTINUOUS MANUFACTURING OF DRUG SUBSTANCES AND DRUG PRODUCTS
- 6 Considerations for Development of Chimeric Antigen Receptor (CAR) T Cell Products-Draft Guidance for Industry
- 7 Evaluation of the quality, safety and efficacy of messenger RNA vaccines for the prevention of infectious diseases: regulatory considerations
- 8 WHO-Guidelines on the quality, safety and efficacy of plasmid DNA vaccines