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hiren ☆ 2010-10-02 17:49 (5328 d 04:12 ago) Posting: # 5982 Views: 5,996 |
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Background: One of my study of enalapril maleate passed cleanely in Cmax and AUC(t) but failed in AUC(inf) AUC(inf) is given an equal (33%) importance in BE criteria. Now AUC(inf) depends on ke value. While preparing the protocol generally time points at elimination phase are kept at distance of around 10-12 hrs (eg of drug with half life of say 20 hrs will have time points of 24.00, 36.00, 48.00, 96.00) and these concentration values give a chaotic ke. I want to know the approach to get the true ke for getting my studies spared from AUC(inf) failure (time points selection base). HP Edit: Category changed. [Helmut] |
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yjlee168 ★★★   Kaohsiung, Taiwan, 2010-10-05 01:45 (5325 d 20:17 ago) @ hiren Posting: # 5993 Views: 4,928 |
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Dear HP, Finally, I heard a BE study failed due to AUC(inf) now. Helmut posted a replied message pointing that a BE study can fail due to AUC(inf) while ago. But I believe it should be rarely seen. Is this a MR dosage form or a special dosage form like patch or anything else? Please search this Forum for the methods of estimating the terminal elimination rate constant (or lambdaz). There should be tons of discussion about it. If you like, you can try bear from http://pkpd.kmu.edu.tw/bear. We have implemented some approaches that we have discussed here with bear. ❝ [...] and these concentration values give a chaotic ke. I want to know the approach to get the true ke for getting my studies spared from AUC(inf) failure (time points selection base). [highlighted by me] the true ke? I do not quite understand what you really mean here. As far as I know, the true ke or the true lambdaz is never known by us. We just estimate it. Please correct me if I am wrong about this. — All the best, -- Yung-jin Lee bear v2.9.2:- created by Hsin-ya Lee & Yung-jin Lee Kaohsiung, Taiwan https://www.pkpd168.com/bear Download link (updated) -> here |
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Helmut ★★★  Vienna, Austria, 2010-10-05 04:24 (5325 d 17:38 ago) @ yjlee168 Posting: # 5995 Views: 4,816 |
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Dear Yung-jin! ❝ […] the true ke or the true lambdaz is never known by us. We just estimate it. Well said.  — 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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hiren ☆ 2010-10-05 18:42 (5325 d 03:19 ago) @ yjlee168 Posting: # 6001 Views: 4,805 |
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Dear Sir, By true Ke I meant the true biological Ke which we estimate by our research. Regarding the dosage form it was an immediate release formulation. And thanks for yr insight on the topic as I am relatively new to this Forum. Hats off to HS DCGI(India) says that the terminal blood samples for a study should not be placed at the distance more than its half life. What is the rational behind it? Any correlation to my previous question for Ke HP |
Ing. Helmut Schütz