Bioequivalence and Bioavailability Forum

❝ Hi!

❝ Bad news for you!

❝ According Capecitabine Product-Specific Bioequivalence Guidance from EMA, Capecitabine is an unstable compound in acidic medium. Absorption is almost complete. The available data on solubility does not allow its BCS classification. Then, I think that a possibility for biowaiver of capecitabine is impossible according current rules.

Hi!
For my mother language isn't English,my English is very poor,and please forgive me
If a drug substance is designated a BCS Class I compound on its properties of being highly solubale,highly permeable and rapidly dissolving drug product,according to BCS waiver industry guidline of FDA and EMA,would I submit the drug product as a BCS waiver and will be passed by FDA?

I'm sorry for my bad English,and still wish to get any answer!