Bioequivalence and Bioavailability Forum

Dear Dr

❝ Kindly be informed that we need to estimate Total Iron as well as Transferrin Bound Iron for Bioequivalence evaluation of Iron Sucrose BE study as per

I have already referred OGD of Iron Sucrose and do know about the analytes to be measured...

❝ FDA's recommendation on Parallel design is based on the Long time taken to eliminate the Transferrin Bound Iron from the body.

Can you provide literature for the same as I have different understanding based on literature available to me????

1. A study with ⁵⁹Fe clearly revealed that drug is cleared from plasma 24hrs after drug administration. This also included transferrin bound ⁵⁹Fe (NDA data)
   
   
2. A bioequivalence study of Fe-sucrose shows below curves for transferrin bound Fe which reveals same concentration at timne 0.00 and 24.00. This even shows that Fe bound to transferrin is cleared by 24hrs.

Regards,
Hiren