Bioequivalence and Bioavailability Forum

Dear Team,

Query is with reference to Erythromycin Ethylsuccinate Tablet BE study Submission to US FDA

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

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?


With regards
AB661