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Dr_Dan ★★ Germany, 2020-05-25 15:22 (1661 d 21:41 ago) Posting: # 21462 Views: 2,527 |
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Dear Forum Members 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.  Thank you very much for your help. — Kind regards and have a nice day Dr_Dan |
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Shuanghe ★★ Spain, 2020-05-26 00:16 (1661 d 12:47 ago) @ Dr_Dan Posting: # 21466 Views: 1,868 |
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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. — All the best, Shuanghe |
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Dr_Dan ★★ Germany, 2020-05-26 13:49 (1660 d 23:14 ago) @ Shuanghe Posting: # 21467 Views: 1,804 |
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Dear Shunghe Thank you so much. Your help is very much appreciated. — Kind regards and have a nice day Dr_Dan |
Ing. Helmut Schütz