Bioequivalence and Bioavailability Forum

Dear Raghu,

Thanks a lot for your response.
We have done the investigation and observed that

❝ 1. Comparison of dissolution data for Pilot batch and Pivotal batch (Pilot Batch >>>> Exhibit Batch)

Its same (more than 90% release in 10 min in all the media e,g 0.1, 0.01, 4.5, 5.8 FeSSIF, FeSSIL V2)

❝ 2. Study Conduct (Fed Breakfast) for Pilot and Pivotal

It is same.

❝ 3. Bio-analytical method validation and Analysis

Even this one is same

Now, we did a repeated biostudy in Fed condition and Bingo!!!
The problem is solved and we got a T/R of more than 100%. ( )
Only changes we made in the protocol was an additional 24 hr housing before dose to minimise the GI empty related variabilites.

This time, there were no double peaks too.

Now what to do?? ()

Does any one have any expirence of submitting this sort of studies?
Can we justify the redosing study on the basis of variable GI motility??

---

Edit: Please use the standard quoting system of the forum. BTW, why did you test pH 0.01 (impossible in humans)? [Jaime]