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Sundar.M ☆ India, 2019-01-07 14:54 (2313 d 22:47 ago) (edited on 2019-01-09 15:55) Posting: # 19743 Views: 4,821 |
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Dear all, Could you please explain how to do endogenous baseline correction using elimination rate constant method. Any reference article(s) regarding the mentioned method would be highly appreciated. Thanks MSMN Edit: Category changed; see also this post #1. [Mittyri] |
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martin ★★ Austria, 2019-01-08 13:24 (2313 d 00:17 ago) @ Sundar.M Posting: # 19759 Views: 3,884 |
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Dear MSMN, I am not aware of a method called "elimination rate constant method" for adjustment of circulating endogenous concentrations. However, you may find this article useful: Bauer, A. & Wolfsegger, M.J. Eur J Clin Pharmacol (2014) 70: 1465. https://doi.org/10.1007/s00228-014-1759-x hope this helps martin Ps.: if the pre-dose sample >LLOQ is due to a residual concentrations arising from a previous dose, then the elimination rate could be used for adjustment of post-dose concentrations under some premises. PPS.: this topic is also mentioned in some regulatory guidelines (e.g. page 9 at https://www.ema.europa.eu/documents/scientific-guideline/guideline-investigation-bioequivalence-rev1_en.pdf) |
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Sundar.M ☆ India, 2019-01-08 18:42 (2312 d 18:59 ago) @ martin Posting: # 19761 Views: 3,846 |
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Thank you Martin. |
Ing. Helmut Schütz