Bioequivalence and Bioavailability Forum

Hi,

❝ Finding information about the CFDA requirements is quite a challenge. It makes finding information about ANVISA requirements seem like a walk in the park

I'm a native speaker and it's difficult for me to find useful information as well. So I guess it's not the issue of the language.

❝ Do you, or does anyone know where I could find more details about reference scaling for the CFDA? Is it similar to EMA scaling as mentioned in the quoted post? Is there anything in the public domain available that can verify this, or am I asking too much???

Not in public domain but I do have a copy of the appendix 9011 from Chinese Pharmacopeia 2015 that was mentioned in my post. I've sent it to Helmut so if he has some spare time to upload it to guidance collection then you'll have it. I'm not sure if this is the verification you referred to.

There's not much new information about BE since the reform from CFDA is quite recent. They do have some training material (given by CFDA staff) which is free to download (rar file), all in Chinese obviously. Both FDA and EMA method was mentioned but they didn't say which one they prefer.

Helmut,

By the way, I thought about sending the guideline to you by forum's private message but I couldn't find a way to attach any document so I use email instead. Is it so by design or my IT skill need to be improved?