Bioequivalence and Bioavailability Forum

The same criterion of Cmax in China now [Study As­sess­ment]

posted by wxp  – China, 2013-05-28 08:10 (4367 d 16:27 ago) – Posting: # 10670
Views: 13,627

Hi, Shuanghe and Helmut,

❝ ❝ From the Xipei's habit of estimating sample size with AUC I assume this is a study for Chinese regulation. If so, the Chinese BE guideline reads that criterion for AUC is 80-125 but for Cmax, hold-on, deep breath, …, 70-143% (and the study doesn't even have to be of replicate design )

❝ Oh wow! With such limits AUC is really the win-loose-metric. Are you referring to the 2005 GL?

等效判断标准，一般规定，经对数转换后的受试制剂的AUC_0→t 在参比 制剂的80％-125％范围，受试制剂的C_max 在参比制剂的70％-143％范围。

The Chinese criteria of Cmax changed in 2010 to 75%~133% according to the latest guideline (Appendix XIXB in Chinese Pharmacopoeia (version 2010)). The criteria of AUC is still 80%~125%.

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

❝ Well, hundreds of products were approved in the EU with those limits – but decades ago…

Chinese regulation improved these years, but there is still no specific guidelines on the BE of HVD. However，Chinese experts are very interested in it.

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

Complete thread:

• Add more subjects after a failed BE study of a HVD wxp 2013-05-27 10:34 [Study As­sess­ment] 
  • 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 nowwxp 2013-05-28 06:10
          • SFDA ⇒ CFDA Helmut 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