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mayur661 ☆ India, 2010-06-02 17:05 (5864 d 16:50 ago) Posting: # 5413 Views: 8,921 |
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Dr_Dan ★★ Germany, 2010-06-02 17:26 (5864 d 16:29 ago) @ mayur661 Posting: # 5415 Views: 7,463 |
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Hi The purpose of a BE study is to detect differences in formulations and it is not necessary to reflect clinical use (that's why you can perform the study in population different to the target population). Therefore you can standardise your dose if you have a two way cross-over design. In a parallel design study you should use body weight adjusted dose to reduce inter-subject variability. Regards Dan — Kind regards and have a nice day Dr_Dan |
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Helmut ★★★   Vienna, Austria, 2010-06-02 21:47 (5864 d 12:08 ago) @ mayur661 Posting: # 5417 Views: 7,513 |
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Dear mayur661, I would suggest to add a more common name to your signature. I agree with Dan; see also this post and the linked document. — 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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kumarnaidu ★ Mumbai, India, 2016-01-11 13:51 (3815 d 19:04 ago) @ Helmut Posting: # 15811 Views: 6,317 |
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Dear All, Recently we did one pilot study on Azithromycin Suspension. In this study we found that the reference drug is showing two peaks. And the study fails for the Cmax. Can anybody suggest what could be the possible reason for getting this kind of concentration curve for reference? — Kumar Naidu |
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Dr_Dan ★★ Germany, 2016-01-12 17:50 (3814 d 15:04 ago) @ kumarnaidu Posting: # 15816 Views: 6,158 |
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Dear kumarnaidu, After oral administration, azithromycin is distributed throughout the entire body. Pharmacokinetic studies have shown clearly higher azithromycin levels in the tissues than in the plasma (up to 50 times the maximum observed concentration in plasma). This indicates that the substance is bound in the tissues in considerable quantities. Kind regards Dr_Dan — Kind regards and have a nice day Dr_Dan |
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nobody nothing 2016-01-13 09:21 (3813 d 23:34 ago) @ Dr_Dan Posting: # 15818 Views: 6,092 |
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Happy new year everybody! Secondary peaks may be caused by: - Discontinuous gastric transit https://www.ncbi.nlm.nih.gov/pubmed/11456119 - Absorption windows throughout the GI tract - Enteroheptic circulation/metabolism+GI cleavage https://www.ncbi.nlm.nih.gov/pubmed/17283195 https://www.ncbi.nlm.nih.gov/pubmed/17201457 - Other things like redistribution from peripheral compartments in a non-linear fashion - Things I forgot or didn't even know  btw: https://www.ncbi.nlm.nih.gov/pubmed/15283305 — Kindest regards, nobody |
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kumarnaidu ★ Mumbai, India, 2016-01-13 12:01 (3813 d 20:53 ago) @ nobody Posting: # 15820 Views: 6,119 |
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Thanks a lot Dr Dan and Nobody. — Kumar Naidu |
Ing. Helmut Schütz