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Srinetram ☆ India, 2010-04-16 20:55 (5906 d 06:30 ago) Posting: # 5155 Views: 7,671 |
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Dear All Regards  I have a confusion. Few days back we did a fed and fast pilot biostudy for a BCS class III molecule with a dose of 1mg and results were encouraging (fasted state with a bit higher CI=98-133% for Cmax and t/r of 100% for fed) When we proceded for pivotal biostudy, the fated state results were same as projected but in fed state we observed t/r of 80% with CI limit of 66-90%. When we loooked in the data, we found that there were number of double peaks (Around 66% of Test and 50% in Reference)which was not observed in pilot. Now we are in confusion that whether it is a formulation realted problem or study related as there is no double peak phemomenon reported for this molecule. Can we do a repeat bio for fed study and justify it using the graphs and differences in the pilot-pivotal 1-pivotal 2 graphs as results if pivotal 2 passes? Please help thanks in advance!!! |
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raghu ★ India, 2010-04-19 19:40 (5903 d 07:46 ago) @ Srinetram Posting: # 5172 Views: 6,291 |
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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 |
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Srinetram ☆ India, 2010-05-21 10:54 (5871 d 16:31 ago) (edited on 2010-05-21 11:46) @ raghu Posting: # 5362 Views: 5,903 |
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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) ❝ 2. Study Conduct (Fed Breakfast) for Pilot and Pivotal ❝ 3. Bio-analytical method validation and Analysis 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] |
Ing. Helmut Schütz