Bioequivalence and Bioavailability Forum

Hi David,

Thank you for your quick reply!

I know that to be replicated the reference product must be administered to the same subject at least two times, but my question was to know if it is mandatory to use the same batch of the reference product or if it allowed to use two different batches of the reference product.

Indeed, we propose to use two different batches of the reference products because we observed in previous PK studies that the reference product is very variable from batch to batch.

I hope it is more clear.

---

Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post #5! [Helmut]