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ElMaestro
Hero

Denmark,
2014-10-11 13:34

Posting: # 13687
Views: 7,358
 

 Reference datasets 2 [Software]

Hi all,

now that reference datasets have been produced and published with (hopefully correct) reference results by some BE wackos I wonder about software PQ.

It can be argued that a system -in this case the computer doing the BE analysis- needs to be kept updated on several fronts and protected from undesired pertubations. It quickly becomes the eternal discussion of isolation versus options of updating. Noone really knows and can control well what goes on when you hook up a computer with e.g. Windows to the internet. There is absolutely no good way of telling the system that any traffic that could cause interference with SAS or WinNonlin or Minesweeper is prohibited while internet connections for good cause is required. You never know if the next anti-virus update screws up a dll of some other software without the user having a chance to know. Restricting access thorugh the fireall for some programs doesn't solve it. And so forth.

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; spend 30 secs literally on running the reference datasets through the stats package, compare the output and tick off the results, and then if the results match conclude that the system is PQ that day and run the necessary analysis?

Would be a minute or two of extra work on the day of analysis, and would require an extra form and possibly a sentence or two in a SOP. And we'd all sleep better.

No?


Edit: Category changed. [Helmut]

“A ten-year, double-blind study from the Mayo Clinic concluded that even in late stages of dementia, the last to go is the lobe of the brain in charge of cafeteria layout.” (Serge Storms/Tim Dorsey).


Best regards,
ElMaestro

- Bootstrapping is a relatively new hobby of mine. I am only 30 years late to the party.
Helmut
Hero
Homepage
Vienna, Austria,
2014-10-17 17:23

@ ElMaestro
Posting: # 13748
Views: 6,632
 

 Templates In Phoenix/WinNonlin

[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.
  • If they match, your form, date and sign it. I would suggest to print out the result table with a timestamp as well. Proceed with your own data.
  • If not, inhale/exhale three times slowly. Count to ten. Open the console and type format c: /q|y . Trash the machine.
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.



[image]Cheers,
Helmut Schütz 
[image]

The quality of responses received is directly proportional to the quality of the question asked. ☼
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jalgorta
Junior

Spain,
2015-05-05 22:45

@ Helmut
Posting: # 14750
Views: 5,274
 

 Templates In Phoenix/WinNonlin

Dear Helmut, unfortunately the FDA RSABE template doesn't work (at least on my hands!!!). I tried many times with an small Full replicate BE study and the first step (Preparation of data set) works fine, but when entering into the analysis the repeated message is ERROR 11051 Parising error. Illegal numeric value. Of course, the data etc are revised several times... Desperate""" Jalgorta


Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post! [Helmut]
Helmut
Hero
Homepage
Vienna, Austria,
2015-05-05 23:00

@ jalgorta
Posting: # 14751
Views: 5,229
 

 Bug or feature?

Hi Jalgorta,

can you send me your data (CSV-format preferred) by e-mail (address over there)? I will have a look ASAP. Please tell me also your Windows version, 32- or 64bit, and the version of Phoenix you are using (I have 6.3.0395 and 6.4.0.768, 32/64bit on my machine).

[image]Cheers,
Helmut Schütz 
[image]

The quality of responses received is directly proportional to the quality of the question asked. ☼
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ElMaestro
Hero

Denmark,
2015-05-06 01:00

@ jalgorta
Posting: # 14752
Views: 5,197
 

 Templates In Phoenix/WinNonlin

Hi Jalgorta,

this may be a dumb question, but I note that Spain uses comma as decimal separator while the US default is a dot. While it sounds trivial to get a dot converted to a comma on import it is anything but. Especially when you have locale settings for both the OS as well as for the compiler used to built the software you are using. So could this come down to a plain comma/dot mismatch in one of Nonlin's importer/helper functions?

“A ten-year, double-blind study from the Mayo Clinic concluded that even in late stages of dementia, the last to go is the lobe of the brain in charge of cafeteria layout.” (Serge Storms/Tim Dorsey).


Best regards,
ElMaestro

- Bootstrapping is a relatively new hobby of mine. I am only 30 years late to the party.
jalgorta
Junior

Spain,
2015-05-06 13:45

@ ElMaestro
Posting: # 14762
Views: 5,165
 

 Templates In Phoenix/WinNonlin

» this may be a dumb question, but I note that Spain uses comma as decimal separator while the US default is a dot. While it sounds trivial to get a dot converted to a comma on import it is anything but. Especially when you have locale settings for both the OS as well as for the compiler used to built the software you are using. So could this come down to a plain comma/dot mismatch in one of Nonlin's importer/helper functions?

Hi ElMaestro, good point (and sometimes works)...but unfortunately before the posting I tried with comma, dot, and without decimals!!! Yesterday I spent more than 10 hours with the trial & error methodology...
Helmut
Hero
Homepage
Vienna, Austria,
2015-05-06 17:55

@ jalgorta
Posting: # 14766
Views: 5,103
 

 Windows locale?

Hi Jaime,

I just send you my project-files. Worked like a charm. I guess (!) something went wrong in "Prepare Dataset for Analysis " – "Determine Order of Formulations" – "Step 2 Transformation". The code for the new column "Data_Ln" is if(flag="N", ln(Data), Data)
In my project the value of Subject 1, Period 1 is displayed as 12.522701 and given in full precision with 12.5227008568555. Identical to yours. In the following "Append Worksheets" I have exactly the same numbers as above, but in yours it is displayed as 1.2522701E+14 and in the cell as 12,5227008568555. If I re-execute this step on my installation, the value changes to the correct one. So it might be a problem related to the locale.

Pharsight recommends to run PHX in EN(US) – which I never did. When I was ~sixteen I decided to use the period as the decimal separator (even in handwriting) because I thought it looks cool and more scientific. :cool:
Therefore, I’m running PHX in a German locale DE(AT), but changed my general Windows-settings to decimal separator period, thousands separator comma, field separator semi­colon. Consider giving it a try on your machine.

I would suggest to register at Certara’s Forum, where you could upload your project-file. They should have a look, IMHO.


PS: Since I code a lot – in all languages I use (R, PHP, SQL, JavaScript) the decimal separator is man­da­torily the period. The comma sucks.

[image]Cheers,
Helmut Schütz 
[image]

The quality of responses received is directly proportional to the quality of the question asked. ☼
Science Quotes
SDavis
Senior
Homepage
UK,
2018-05-02 15:46

@ jalgorta
Posting: # 18751
Views: 372
 

 Templates In Phoenix/WinNonlin

Apologies for replying to such an old thread but just today I was answering a question on RSABE that caused me to check Helmut's excellent repository and I only just saw it.

Hopefuly you and others have worked this out but absolutely your data should have decimal places defined by point as the separator. I would recommend actually that you change your regional settings to use decimal point and restart Phoenix to ensure this is consistent, see pages 8&9 of the Getting Started guide (within menu, Help>Documents)

[image]

Simon

Simon
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