Bioequivalence and Bioavailability Forum

Hello AB661

❝ For Erythromycin Ethylsuccinate whether there are any literature evidences to provide that it is Highly variable drug.

You need to check with data

❝ Also, as per current OGD BE recommendation bioequivalence to be established based on Erythromycin Ethylsuccinate. But Erythromycin Ethylsuccinate is unstable in plasma and rapidly hydrolyzed to Erythromycin. Measuring analyte as erythromycin Ethylsuccinate will not give reliable result. Instead of Erythromycin Ethylsuccinate total Erythromycin to be measured. Can you please provide comments on this aspect?

There are methods available and so develop accordingly. As the AE with ethylsuccinate are less, it also makes sense to analyze them. PSG recommends BE based on parent salt form, and free base as supportive evidence.

Divyen