no lambda(z), no NCA? [NCA / SHAM]

posted by yjlee168 Homepage – Kaohsiung, Taiwan, 2009-07-16 09:53  – Posting: # 3957
Views: 9,868

(edited by yjlee168 on 2009-07-16 10:06)

Dear Helmut,

Thank you for your messages.

» Most people would do so – although I’ve seen others who took samples after τ.

For what purpose to take blood sample after tau? Is it worth to do so?

» We should be cautious in using ‘terminal phase’ – especially in NCA. Personally I prefer ‘apparent elimination’ [...]

Absolutely agree.

» In steady state within τ you may get a value similar to SD, but with noisy data – and if more than one compartment is needed to describe [...]

So, it looks like that no lambdaz, no NCA... :-(

» Tricky. I would not try to play around with elimination from steady state within tau.

It is inevitable for us in Taiwan or in China to conduct a multiple-dose BE/BA study when the target product is modified release dosage form.

» Accumulation index is easy – and actually the most interesting metric if we compare SD with MD. I only use
»      AUC0-τ   (steady state)
» R = ───────
»      AUC0-∞   (single dose)

The formula is only for when conducting both a SD and a MD BE/BA studies simultaneously. If we just have a MD BE study, we still need a lambdaz.

» Vss is a strange metric. It sounds so easy to divide the

Indeed. We calculate Vss just because WinNonlin does so. Not a necessary procedure in a BE study.

» That’s rubbish. WinNonlin uses
»           1
» R = ──────────────
»     |1 – ℯ –λz × τ|
» which needs λz, a constant τ (what about a dose regimen of 6/6/12 or actual sampling times?), and is only valid for a one-compartmental model (the most serious drawback).[...]

Good point!
Since we're about to release next version (v2.3.3) of bear, we added data analysis for MD BE/BA since this release. I used to estimate lambdaz of MD study with the same method that we did in SD study. However, I was not very comfortable to do so for a long time.

All the best,
-- Yung-jin Lee
bear v2.8.7:- created by Hsin-ya Lee & Yung-jin Lee
Kaohsiung, Taiwan http://pkpd.kmu.edu.tw/bear
Download link (updated) -> here

Complete thread:

Activity
 Admin contact
20,142 posts in 4,248 threads, 1,387 registered users;
online 5 (0 registered, 5 guests [including 2 identified bots]).
Forum time (Europe/Vienna): 08:30 UTC

Maturity is the capacity to endure uncertainty.    John Finley

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