Sundar.M
☆    

India,
2019-01-07 12:54
(edited by mittyri on 2019-01-09 14:55)

Posting: # 19743
Views: 1,179
 

 Baseline correction method [NCA / SHAM]

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]
martin
★★  

Austria,
2019-01-08 11:24

@ Sundar.M
Posting: # 19759
Views: 976
 

 Baseline correction method

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)
Sundar.M
☆    

India,
2019-01-08 16:42

@ martin
Posting: # 19761
Views: 973
 

 Baseline correction method

Thank you Martin.
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