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kobe ☆ France, 2009-06-17 13:55 (5800 d 04:15 ago) Posting: # 3864 Views: 7,049 |
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Hello, My concern is about accumulation ratio calculation after repeated administration of IR product. Our study design was as follows: 2 periods for food effect assessment followed by 1 MD period (administration every 12h) where subjects received breakfast before administration. 1 sample collection was made for PK at the end of MD period. We would like to calculate accumulation ratio but we do not have single dose PK result from the MD period to assess it. We have thought to use results from food effect for this assessment to get the information. However, which results could we use according to you? fast period? but subjects received usual breakfast during MD period fed period? it seems to be the best solution as no food effect was shown for AUC parameter but food effect was observed for Cmax. Second question, which formula could we use to assess this ratio? I hope my question sounds clear enough.. Thanks by advance for your help Kobe |
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Helmut ★★★   Vienna, Austria, 2009-06-17 16:11 (5800 d 02:00 ago) @ kobe Posting: # 3867 Views: 5,548 |
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Dear Kobe! ❝ However, which results could we use according to you? ❝ fast period? but subjects received usual breakfast during MD period fed period? it seems to be the best solution as no food effect was shown for AUC parameter but food effect was observed for Cmax. ![[image]](img/uploaded/image485.png) I would compare MD with fasting SD – since a “normal breakfast” IMHO is closer to fasting than the high-calory high-fed type in the food SD period. However, you are still comparing apples and oranges…❝ Second question, which formula could we use to assess this ratio? Just the ratio of any MD-metric to the SD-metric (AUC, Cmax, or even C12 as some kind of “pseudo-trough”). — 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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kobe ☆ France, 2009-06-17 17:57 (5800 d 00:14 ago) @ Helmut Posting: # 3868 Views: 5,762 |
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Dear Helmut, I am sure your right, that is a unusual procedure. But it will be consiered as an exploratory analysis only. Do you think that the following formula for the calculation of the ratio is correct according to you ? Accumulation ratio=AUC12 MD/AUC12 SD Thanks again for your help Kobe -- Edit: Full quote removed. Please delete anything from the text of the original poster which is not necessary in understanding your answer; see also this post! [Helmut] |
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Helmut ★★★ Vienna, Austria, 2009-06-17 18:02 (5800 d 00:09 ago) @ kobe Posting: # 3869 Views: 5,208 |
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Dear Kobe! ❝ Do you think that the following formula for the calculation of the ratio is correct according to you ? ❝ Accumulation ratio=AUC12 MD/AUC12 SD Yes, I think so. — 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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kobe ☆ France, 2009-06-17 20:18 (5799 d 21:53 ago) @ Helmut Posting: # 3870 Views: 5,255 |
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Thanks for your help! |
Ing. Helmut Schütz