Bioequivalence and Bioavailability Forum

Hi,

❝ As per the Guideline, for CFDA submissions, pharmacokinetic parameters CL, Vd and F needs to be submitted

❝

❝ This one (page 17)?

No longer true.

BE guideline linked by Helmut was from 2005 and it was updated by CFDA in 2015 (as an appendix in Chinese Pharmacopeia 2015 Edition) and it's basically a copy of EMA's BE guideline (with some missing information). However, in 2016, they also published another BE guideline (3rd attachment, in Chinese), which is basically a copy from FDA's BE guidance. So it's a bit of mess now as you can imagine. e.g., FDA and EMA has quite different opinion about fasting and/or fed study for solid oral immediate-release dosage forms (depending on SPC's recommended administration method), in addition to many other aspects. Which guideline should one follow?

I recently helped to review a BE protocol in China and they follow the newer guideline. So FDA beats EMA in China so to speak. . e.g., for the IR oral dosage I reviewed, instead of fasting BE only they will do both fasting and fed.

There are many other things to consider. One thing I'm sure is that all those parameters, or metric as Helmut prefer , mentioned above are no longer required.

So MMW, I'd suggest that you talk to some guys in China to have updated info. before you do anything.