BCS classification and biowaiver eligibility.
BCS class | Solubility | Permeability | Biowaiver eligibility |
---|---|---|---|
I | High | High | Eligible |
II | Low | High | Eligible only for weak acids having high solubility at pH 6.8 and high dissolution rate |
III | High | Low | Eligible if very rapid dissolution rate |
IV | Low | Low | Not eligible |