Bioequivalence and Bioavailability Forum

SFDA ⇒ CFDA [Study As­sess­ment]

posted by Helmut  – Vienna, Austria, 2013-05-28 15:02 (4775 d 09:13 ago) – Posting: # 10674
Views: 16,739

Hi Xipei!

❝ The Chinese criteria of Cmax changed in 2010 to 75%~133% according to the latest guideline (Appendix XIXB in Chinese Pharmacopoeia (version 2010)).

THX, good to know!

❝ Helmut, it really surprised me that you can read Chinese.

I can’t. I only know how to copy/paste and work with Google-translate.

❝ P.S. Chinese FDA changed the name to China Food and Drug Administration (CFDA)

THX again. I updated the Guideline-collection accordingly.

—
Dif-tor heh smusma 🖖🏼 Довге життя Україна! 
Helmut Schütz


The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes

Complete thread:

• Add more subjects after a failed BE study of a HVD wxp 2013-05-27 10:34 
  • bad luck Dr_Dan 2013-05-27 12:28
    • bad luck wxp 2013-05-27 14:19
  • Beware of Add-on Studies! Helmut 2013-05-27 13:51
    • Beware of Add-on Studies! Shuanghe 2013-05-27 15:59
      • Oh wow! Helmut 2013-05-27 16:21
        • The same criterion of Cmax in China now wxp 2013-05-28 06:10
          • SFDA ⇒ CFDAHelmut 2013-05-28 13:02
            • Helmut, updated Chinese BE guideline here Shuanghe 2013-06-14 11:05
              • BE in Chinese Pharmacopoeia Helmut 2013-06-14 14:22
                • BE in Chinese Pharmacopoeia Shuanghe 2013-06-14 14:56
                  • BE in Chinese Pharmacopoeia Helmut 2013-06-14 16:11
    • Add more subjects after a failed BE study of a HVD wxp 2013-05-28 05:13
      • Still many subjects… Helmut 2013-05-28 12:56