Bioequivalence and Bioavailability Forum

ramesh_7779 ★ 2011-03-26 11:05 (5152 d 21:13 ago) (edited on 2011-03-26 14:57) Posting: # 6815 Views: 5,074	Clast greater than 20 % LLOQ value [NCA / SHAM] Post reply
	Dear All, Can anybody suggest what one should do in the below mentioned case. If the last collected time point has a concentration greater than 20 % of the lower limit of quantification value. should i report AUC0-inf, Kel, and t1/2 in that case or not. Regards Ramesh Edit: Category and subject line changed. [Jaime]

Jaime_R
★★

Barcelona,
2011-03-26 16:14
(5152 d 16:04 ago)

@ ramesh_7779
Posting: # 6817
Views: 3,996

Clast <LLOQ

Post reply

Dear Ramesh!

❝ If the last collected time point has a concentration greater than 20 % of the lower limit of quantification value.

❝ should i report AUC0-inf, Kel, and t1/2 in that case or not.

Any value below the LLOQ should be reported as e.g. 'BLQ' (whether this value is >20% of LLOQ or not doesn't make a difference).
Calculate AUC_t to the time-point before the last collected (i.e. to the last time point where C>LLOQ).
Extrapolate as usual.

I guess you are not aiming at truncated AUC₇₂ - where extrapolation is not needed at all. If you are going with AUC₇₂ it is an open issue whether you should use an estimate of C₇₂ or not. You may end up with a situation where the C₇₂ after one formulation is below the LLOQ and above LLOQ after the other. This might bias your T/R-ratio. Search the forum for apples and oranges (e.g. this post).

—
Regards, Jaime

Clast greater than 20 % LLOQ value [NCA / SHAM]

Clast <LLOQ