Bioequivalence and Bioavailability Forum

Dear Srinetram,

There are several possibilities of variations B/W Pilot and Pivotal results for the Expected results and what you have got.

Just you have to do the investigation and identify the root cause for this variation of results and it will starts form

1. Comparison of dissolution data for Pilot batch and Pivotal batch (Pilot Batch >>>> Exhibit Batch)
2. Study Conduct (Fed Breakfast) for Pilot and Pivotal
3. Bio-analytical method validation and Analysis

If there are no variations for pilot and pivotal for point no. 01 and variations in either point no 2 or 3 you can use the same batch for Fed biostudy and vice versa.

Hope this may helps you

Regards

Raghavender.Chenna