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Rahul ☆ India, 2008-12-01 07:59 (6412 d 02:15 ago) Posting: # 2839 Views: 5,747 |
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Dear Sir, I have some queries regarding conduction of BE study of Tacrolimus. We are planing to do cross-over BE pilot study. I have refered some previous studies, in which washout period is kept 14 days for some and 21 days for some studies. we are planing to keep 14 days washout period and sampling upto 120.00 hrs. i thing we have to increase sampling hrs. and 14 days wash-out period is okay? if yes, plz justify. Here, in this case we have to do "whole blood analysis". So i want to ask that, which cretical points should be cosidered while doing "W.B.A." and how mush amount of blood is sufficient to carry out "W.B.A." Please guide me regarding above issues. — Thanks n regards, Rahul... |
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chidambarajoshi ★ Hyderabad-INDIA, 2008-12-01 08:33 (6412 d 01:41 ago) @ Rahul Posting: # 2840 Views: 5,003 |
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Dear Rahul ❝ which cretical points should be cosidered while doing "W.B.A." and ❝ how mush amount of blood is sufficient to carry out "W.B.A." Regards, Joshi — Best Regards Joshi |
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Rahul ☆ India, 2008-12-01 12:03 (6411 d 22:11 ago) @ chidambarajoshi Posting: # 2845 Views: 5,056 |
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Dear Mr. Joshi, First of all thanxs for your reply. We are planing to do BE study on Tacrolimus Capsule 5 mg. Expected Pharmacokinetics:- 1. Tmax: 1.6 + 0.7 hrs 2. Cmax: 29.7 + 7.2 ng/ml 3. t1/2: 34.8 + 11.4 Waiting for your further guidance. Thankx n Regards, Rahul Pol. -- Edit: Full quote removed. Please see this post! [Helmut] — Thanks n regards, Rahul... |
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chidambarajoshi ★ Hyderabad-INDIA, 2008-12-02 07:23 (6411 d 02:51 ago) @ Rahul Posting: # 2850 Views: 4,854 |
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Dear Rahul, ❝ Expected Pharmacokinetics:- ❝ 1. Tmax: 1.6 + 0.7 hrs ❝ 2. Cmax: 29.7 + 7.2 ng/ml ❝ 3. t1/2: 34.8 + 11.4 For this you may require 3-3.5 mL of blood (for both aliquotes). You can use Sirolimus as IS for BA methoh. Pl refer the following paper for method. It's my paper  Chromatogr B Analyt Technol Biomed Life Sci. 2004 Jun 5;805 (1):13-20 Regards Joshi — Best Regards Joshi |
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Rahul ☆ India, 2008-12-02 14:32 (6410 d 19:41 ago) @ chidambarajoshi Posting: # 2866 Views: 4,892 |
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Dear Sir, will i get full article of your's entitled:- Chromatogr B Analyt Technol Biomed Life Sci. 2004 Jun 5;805 (1):13-20 Any is it really necessary to keep washout period of 21 days? if yes, why? -- Edit: Full quote removed. Please see this post! [Ohlbe] — Thanks n regards, Rahul... |
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BEAZ ★ India, 2008-12-02 08:21 (6411 d 01:53 ago) @ Rahul Posting: # 2853 Views: 4,807 |
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Dear Rahul, ❝ we are planing to keep 14 days washout period and sampling upto 120.00 hrs. i thing we have to increase sampling hrs. and 14 days wash-out period is okay? if yes, plz justify. 14 days is ok. half life (+ SD) will be around 46hr if you calculate 7 half life 46*7 = 322 hr. exactly 14 days is more than enough for complete elimination. ❝ Here, in this case we have to do "whole blood analysis". So i want to ask that, which cretical points should be cosidered while doing "W.B.A." and how mush amount of blood is sufficient to carry out "W.B.A." check with your bioanalytical team, 5ml is sufficient or refer other replays. regards — Alhas |
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chidambarajoshi ★ Hyderabad-INDIA, 2008-12-02 10:10 (6411 d 00:03 ago) (edited on 2008-12-03 06:20) @ BEAZ Posting: # 2856 Views: 4,728 |
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Dear Rahul, ❝ exactly 14 days is more than enough for complete elimination I doubt this is enough since this is RBC bound drug. 21 days will be ok i beleive Joshi — Best Regards Joshi |
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Rahul ☆ India, 2008-12-02 14:42 (6410 d 19:32 ago) @ BEAZ Posting: # 2867 Views: 4,900 |
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Dear Alhas, Thanks for your reply. I have some articles on BE study of Tacrolimus, some of which have 14 days wash-out period and others 21 days... I need the reason why to go for 14 or 21? I wont have full text articles, thatswhy I unable to conclude. -- Edit: Full quote removed. Please see this post! [Ohlbe] — Thanks n regards, Rahul... |
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chidambarajoshi ★ Hyderabad-INDIA, 2008-12-03 06:20 (6410 d 03:54 ago) (edited on 2008-12-03 06:32) @ Rahul Posting: # 2868 Views: 4,928 |
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Dear Rahul ❝ I have some articles on BE study of Tacrolimus, some of which have 14 days wash-out period and others 21 days... Yes..! But 14 days will always have carry over in pre-dose sample of period-II (I had experienced). So I strongly recommend 21 days where there will not be carryover. B'coz it's RBC bound drug. And t1/2: 34.8 ± 11.4. So if you consider 10 times of t1/2 it will approx 20 days. — Best Regards Joshi |
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Helmut ★★★   Vienna, Austria, 2008-12-03 08:48 (6410 d 01:26 ago) @ chidambarajoshi Posting: # 2871 Views: 4,938 |
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Dear all, just a general comment on the estimation of a wash-out. Your arguments actually used either the mean or the mean ± SD, 7 or 10 times the half-life, … Remember that 34.8 ± 11.4 = 46.2 hrs (assuming a normal distribution) cover 84% of half-lives one may observe in subjects. It may be reasonable to go with an upper 95% confidence interval (Z0.95=1.64) instead: 34.8 + 1.64×11.4 = 53.6 and continue with 7 half-lives: 375 hr (about 16 days). If Joshi experienced problems with carry-over after 14 days, I would simply follow his advice and go for 21 days. — 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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BEAZ ★ India, 2008-12-03 08:31 (6410 d 01:43 ago) @ Rahul Posting: # 2869 Views: 4,793 |
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Dear Rahul, Hope Mr. Joshi's mail suffice ur query. For safer side always provide a sufficient washout. Regards — Alhas |
Ing. Helmut Schütz