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

posted by Astea – Russia, 2019-02-10 20:50  – Posting: # 19898
Views: 1,217

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?

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