Bioequivalence and Bioavailability Forum

Dear Mr Hiren,

❝ OGD recomendation for Iron Sucrose Injection suggest Parallel design even though the half life is around 6-7 hrs. What can be the rationale for it?

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 FDA's Individual Product Recommendation on Iron Sucrose. FDA's Suggestion for Parallel design is not based on the half life of the iron which is around 6 hours. But, FDA's recommendation on Parallel design is based on the Long time taken to eliminate the Transferrin Bound Iron from the body.

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❝ Along with it they also recommend reference replicate design if one suspects high variability.

The pharmacokinetics parameters of Total Iron/Transferrin Bound Iron has high Intrasubject Variability. Hence, FDA is suggesting for Reference-scaled average bioequivalence approach.