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wanabby ☆ 2012-09-26 05:45 (5012 d 02:15 ago) Posting: # 9257 Views: 8,963 |
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Dear all We conducted a BE study for a BCS 2 drug, we evaluated dissolution rate of Test and R products before BE study, We thought the dissolution rate was Similar, then we conduct the study. But the result of the study make us shocked, especially the opposite results in fasting and Fed STUDY. The results are as follows: ![[image]](img/uploaded/image37.jpg) I think the results are very weird, as the trendency was opposite in both studies. Here, could you all pls give me a hand for explanation? Thanks a million! So I Go back to have a look at the dissolution rate in vitro as follows: ![[image]](img/uploaded/image38.jpg) Here, could you all pls give me a hand for explanation? Thanks a million! Abby |
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Helmut ★★★   Vienna, Austria, 2012-09-26 16:20 (5011 d 15:40 ago) @ wanabby Posting: # 9263 Views: 7,669 |
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Hi Abby! ❝ We conducted a BE study… From your CIs and CVs I guess the sample size was only 11. Is this correct? If yes, these were pilot studies – good idea! ❝ … for a BCS 2 drug, we evaluated dissolution rate of Test and R products before BE study, We thought the dissolution rate was Similar, then we conduct the study. For class II drugs prediction of in-vivo performance from dissolution may – or may not – work. Your f2-values with 62–74 are not that good. ❝ But the result of the study make us shocked, especially the opposite results in fasting and Fed STUDY. Bad luck. I’m afraid you have to reformulate. Try to get a better match with the reference in vitro first. It’s possible that excipient(s) are responsible for these differences as well (since fasting/fed show opposite ratios). — Dif-tor heh smusma 🖖🏼 Довге життя Україна! ![[image]](https://static.bebac.at/pics/Blue_and_yellow_ribbon_UA.png) Helmut Schütz ![[image]](https://static.bebac.at/img/CC by.png) The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
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jag009 ★★★ NJ, 2012-09-27 23:29 (5010 d 08:31 ago) @ wanabby Posting: # 9271 Views: 7,656 |
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John |
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Helmut ★★★ Vienna, Austria, 2012-09-29 16:00 (5008 d 16:00 ago) @ jag009 Posting: # 9280 Views: 7,610 |
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Hi John! ❝ 1a) Effect of food on the excipients of the test product resulting in a drastic change in the bioavailability of the test and ref product? 1b) Effect of food on the excipients of the reference product…  — Dif-tor heh smusma 🖖🏼 Довге життя Україна! Helmut Schütz The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
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jag009 ★★★ NJ, 2012-10-02 00:35 (5006 d 07:25 ago) @ Helmut Posting: # 9293 Views: 7,644 |
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My bad.  I meant effect of food on the excipient of the test product. With this kind of data, I would look at the ratios for fast and fed. I think in this case, as suggested by Helmut (small sample size), might be a better indicator for you. Looks bad IMHO, the test formulation was too high in bio (Cmax and AUC) under fasting and too low under fed. Big food effect. What is the Tmax values? median please. Check potency difference? John |
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Helmut ★★★ Vienna, Austria, 2012-10-02 21:58 (5005 d 10:03 ago) @ jag009 Posting: # 9301 Views: 7,558 |
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Hi John! ❝ I meant effect of food on the excipient of the test product. I know. And I meant effect of food on the excipient of the reference product. We simply don’t know unless we dose a solution in a third arm. — Dif-tor heh smusma 🖖🏼 Довге життя Україна! Helmut Schütz The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
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ElMaestro ★★★ Denmark, 2012-10-02 01:06 (5006 d 06:55 ago) @ wanabby Posting: # 9294 Views: 7,515 |
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Hello wanabby, interesting. I shall not volunteer any suggestions at this time, but could you comment on the following:
— Pass or fail! ElMaestro |
Ing. Helmut Schütz