Bioequivalence and Bioavailability Forum 22:04 CET

Main page Policy/Terms of Use Abbreviations Latest Posts

 Log in |  Register |  Search

Templates In Phoenix/WinNonlin [Software]

posted by Helmut Homepage - Vienna, Austria, 2014-10-17 17:23  - Posting: # 13748
Views: 8,634

[image]Hi ElMaestro,

» So I wonder wouldn't it be very solid and a good idea to simply perform some degree of PQ "every day" or "immediately before" a reported analysis; […]

I like the idea very much!

» No?

Yes!

To the right one of the RSABE-templates* we developed last year. Both reference datasets from EMA’s Q&A-document are part of the pro­ject-file. It’s foolproof (I hope):
Two PDFs are directly accessible: The Q&A itself and a step-by-step instruction how to import data, map variables, perform the ana­lysis, :blahblah:

After entering #1-3 in the Data-section, in #4 of the Workflow the desired dataset is chosen. Run EMA’s examples first. There is a table in the out­put where the actual results can be com­pared to the ones reported by the al­mighty oracle.
It’s straightforward to set up a similar template for 2×2 cross-overs containing our reference datasets. No big deal.

» […] if the results match conclude that the system is PQ that day and run the necessary analysis?

I guess in any software one could modify the code after the check and before the analysis, right? But that’s plain fraud and not the topic of this thread.



Cheers,
Helmut Schütz
[image]

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

Complete thread:

Activity
 Mix view
Bioequivalence and Bioavailability Forum |  Admin contact
18,934 posts in 4,039 threads, 1,287 registered users;
online 9 (1 registered, 8 guests [including 7 identified bots]).

There are no such things as applied sciences,
only applications of science.    Louis Pasteur

The BIOEQUIVALENCE / BIOAVAILABILITY FORUM is hosted by
BEBAC Ing. Helmut Schütz
HTML5 RSS Feed