Bioequivalence and Bioavailability Forum

Dear All,

There are many more discussions are available on clinical development for generic version of Iron Sucrose Injection. EMA and FDA has different approaches regarding BE study of Iron Sucrose Injection.

According to the FDA's present draft guidance on Iron Sucrose, bioequivalence should be based on "Maximum value of the difference in concentration between Total Iron and Transferrin-bound Iron over all time points measure."

Could anyone please elaborate FDAs thinking behind this criteria for evaluation?

Thanks in advance

MMW

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Edit: Guidance linked; see also this post #3. [Helmut]