【分享】FDA的三个指导原则翻译
发布于 2013-11-25 · 浏览 5636 · IP 上海上海
这个帖子发布于 11 年零 170 天前，其中的信息可能已发生改变或有所发展。
尝试翻译的FDA的以下三个指导原则，供大家指正。
| Biosimilarity | Guidance for Industry on Biosimilars: Q & As Regarding Implementation of the BPCI Act of 2009 | Draft GuidanceUpdated for 508 on 3/22/12. | 02/09/12 |
| Biosimilarity | Scientific Considerations in Demonstrating Biosimilarity to a Reference Product (PDF - 576KB) | Draft Guidance | 02/09/12 |
| Biosimilarity | Quality Considerations in Demonstrating Biosimilarity to a Reference Protein Product (PDF - 432KB) | Draft Guidance | 02/09/12 |
最后编辑于 2022-10-09 · 浏览 5636
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