AB661
☆    

India,
2025-04-02 13:39
(51 d 11:38 ago)

(edited on 2025-04-02 13:56)
Posting: # 24391
Views: 1,122
 

 Erythromycin Ethyl­succinate Tablet [Regulatives / Guidelines]

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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
 
dshah
★★  

India,
2025-04-10 07:19
(43 d 17:58 ago)

@ AB661
Posting: # 24397
Views: 777
 

 Erythromycin Ethyl­succinate Tablet

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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
 
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