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Baseline correction method [NCA / SHAM]

posted by martin - Austria, 2019-01-08 12:24  - Posting: # 19759
Views: 236

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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