Trilogy? [NCA / SHAM]

posted by Helmut Homepage – Vienna, Austria, 2016-01-29 14:31 (2981 d 01:47 ago) – Posting: # 15892
Views: 6,516

Hi Shuanghe,

❝ Didn't know it's a trilogy!


So do I. I don’t have the slightest intention to dive into validating NCA-algos. I think everybody should describe unambiguously in the protocol how it will be done (example). In this respect I concur with Sauter’s quote. In the majority (!) of reports I have seen the interval used for estimating λz is not given. If one wants to recalculate results it means a lot of trial and error. Especially how BQLs are treated deserves special attention. How are partial AUCs (or AUC0–72) calculated if a sample is not taken exactly at the cut-off time? Does the software interpolate (and if yes, how)? t75% (“plateau time” or “peak occupancy time 75%”; mandatory for MR in Russia) can be tricky. In the EU the peak-trough-fluctuation in BE should be calculated with Css,min at τ, whereas in BA (new drugs) Css,min within τ should be used. Only the latter is the standard in software.

BTW, if (if!) the algo is described in the protocol, recalculation is possible with a pocket calculator or even paper-pencil-brain. I don’t understand the agitation.

❝ So when can we expect "The Return of the King" (SCNR :-D)? Don't keep us waiting.


Maybe it is like Patrick Rothfuss’ The Kingkiller Chronicle. Fans of fantasy fiction are waiting since 2011 for the third book.

Dif-tor heh smusma 🖖🏼 Довге життя Україна! [image]
Helmut Schütz
[image]

The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes

Complete thread:

UA Flag
Activity
 Admin contact
22,957 posts in 4,819 threads, 1,638 registered users;
81 visitors (0 registered, 81 guests [including 11 identified bots]).
Forum time: 16:19 CET (Europe/Vienna)

Nothing shows a lack of mathematical education more
than an overly precise calculation.    Carl Friedrich Gauß

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