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Registerlink to Chinese BE-Guideline [Regulatives / Guidelines]
Dear Dan,
» Could anybody provide the correct link to the Chinese BE-Guideline? http://www.sfda.gov.cn/directory/web/WS01/images/MjAxNsTqtdo2MbrFzai45ri9vP4zLmRvY3g=.docx
» as mentioned under BEBAC/Guidelines/China gives an error message.
They changed the website. You can find all guidance at this link.
Specifically, Guidance for PK-based BE, for HVDP, and for statistics.
The general link above contains much more (for chemical compounds) in case you are interested. For others such as biological products, follow the link in the left panel on that pages.
» Could anybody provide the correct link to the Chinese BE-Guideline? http://www.sfda.gov.cn/directory/web/WS01/images/MjAxNsTqtdo2MbrFzai45ri9vP4zLmRvY3g=.docx
» as mentioned under BEBAC/Guidelines/China gives an error message.
They changed the website. You can find all guidance at this link.
Specifically, Guidance for PK-based BE, for HVDP, and for statistics.
The general link above contains much more (for chemical compounds) in case you are interested. For others such as biological products, follow the link in the left panel on that pages.
—
All the best,
Shuanghe
All the best,
Shuanghe
Complete thread:
- link to Chinese BE-Guideline Dr_Dan 2020-05-25 13:22 [Regulatives / Guidelines]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- link to Chinese BE-GuidelineShuanghe 2020-05-25 22:16
- link to Chinese BE-Guideline Dr_Dan 2020-05-26 11:49
- link to Chinese BE-GuidelineShuanghe 2020-05-25 22:16
Ing. Helmut Schütz