Sundar.M
☆    

India,
2019-01-07 14:54
(1726 d 12:04 ago)

(edited by mittyri on 2019-01-09 15:55)
Posting: # 19743
Views: 3,249
 

 Baseline correction method [NCA / SHAM]

Post reply
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 13:24
(1725 d 13:34 ago)

@ Sundar.M
Posting: # 19759
Views: 2,701
 

 Baseline correction method

Post reply
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 18:42
(1725 d 08:16 ago)

@ martin
Posting: # 19761
Views: 2,671
 

 Baseline correction method

Post reply
Thank you Martin.
 
UA Flag
Activity
 Admin contact
22,763 posts in 4,775 threads, 1,627 registered users;
17 visitors (0 registered, 17 guests [including 11 identified bots]).
Forum time: 03:59 CEST (Europe/Vienna)

We should not speak so that it is possible
for the audience to understand us,
but so that it is impossible
for them to misunderstand us.    Quintilian

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5