Cτ for lin and lin-up/log-down [NCA / SHAM]

posted by Astea – Russia, 2019-02-10 20:50  – Posting: # 19898
Views: 3,410

Dear Helmut!

I'm grateful for your quick reply!

» By the linear trapezoidal method (dammit!)… With lin-up/log-down I get 1298.

For some reason (may be for it's simplicity) russians like linear method and include it into the protocols.

I recalculated via lin-up/log-down and now I'm puzzled with a new question: why do Cτ's differ by the way of calculation AUC? For linear I've got 3,38... (by the way, what are (1) and (2) on your presentation, slide 18?)

» Let’s call the first two datapoints t0|C0...

Is it correct to use t0 and t1, if dosing time happened between this two points? I mean for the time before dose (t0), the curve should be decreasing exponentially, while for the t1 it should be rising similar to linear?

» » What is the best way to handle with BLQ in the end of the dosing period for steady-state?
» Lin-up/log-down as usual. Don’t you have any accumulation or is the method lousy? ;-)

I was lucky enough not to get it till now but shit happens, you know, and a danger foreseen is half avoided. Is it a bad idea to miss that BLQ for ss elimination part?

What is about regulatory's acceptance of any of the calculation modifications? I may use profound methods of numeric integration, but would it be accepted?

"We are such stuff as dreams are made on, and our little life, is rounded with a sleep"

Complete thread:

Activity
 Admin contact
20,135 posts in 4,245 threads, 1,385 registered users;
online 3 (0 registered, 3 guests [including 3 identified bots]).
Forum time (Europe/Vienna): 03:00 CET

In the beginner’s mind there are many possibilities.
In the expert’s mind there are few.    Shunryu Suzuki

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