Biowaiver Considerations for Sustained-Release (SR) Dosage Forms
A biowaiver for a sustained-release (SR) dosage form is generally more challenging to obtain compared to immediate-release (IR) forms due to the complexity of drug release mechanisms and potential impact on bioavailability. However, under certain conditions, a biowaiver may be possible based on in vitro dissolution studies and in vivo-in vitro correlation (IVIVC). Key Considerations…