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anbu ☆ India, 2011-10-13 18:52 (5367 d 05:32 ago) Posting: # 7479 Views: 3,811 |
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hi sir kindly help how to calculate time points based on cmax. and how to calculate wash out period for usa regulation Edit: Category changed. [Helmut] |
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ElMaestro ★★★ Denmark, 2011-10-13 19:23 (5367 d 05:02 ago) @ anbu Posting: # 7480 Views: 3,216 |
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Hello anbu, ❝ kindly help how to calculate time points based on cmax. You mean tmax. I use the following rules of thumb, and there's of course room for deviations: ~22 points in total. 6 points prior to tmax, and similar dense sampling after the expected tmax. The last 5-6 points resonably evenly spaced in time. For some of the products I work with tmax is less than 8 minutes or sumfin and in such situations it is a good idea to spank the PI a little bit and ask her/him what the shortest span of time between two samples is and plan accordingly. Best regards, EM. |
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Dr_Dan ★★ Germany, 2011-10-14 11:38 (5366 d 12:47 ago) @ anbu Posting: # 7493 Views: 3,117 |
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Hi For an expected tmax = 3-4 h the blood sampling schedule could be like this: The first blood sample should be collected prior to drug administration while the others are collected 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 7, 9, 12, 16, 24, 36, and 48 hours post drug administration. You need to ensure that the first post-dose sample does not represent the Cmax. A wash out period 5 times the t1/2 is expected to be enough. Hope this helps Kind regards Dan — Kind regards and have a nice day Dr_Dan |
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anbu ☆ India, 2011-10-17 23:24 (5363 d 01:01 ago) @ Dr_Dan Posting: # 7506 Views: 3,006 |
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hello sir i understood about the wash out period. but not time point calculation. i don't know how many time points has to come before tmax and after tmax 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! [Ohlbe] |
Ing. Helmut Schütz