10 replies to this topic

[Angus McLean]

Dear All: I am following the document "How to Execute the FDA RSABE Template from Phoenix 1.3" from Pharsight. It is a step step guide that provides a step by step guide how to perform this in Phoenix and it an excellent Initiative. There are lots of details and indeed warnings of what not to do.
I have progressed and come to a step that I do not follow. I have imported full replicate from Excel and I have set up the files as directed until I have completed mapping at step 8 involving mapping the data and pressing the execute button.
The step I do not understand is at step 9.
a) Select “Prepare Dataset for Analysis “ workflow. And EXECUTE EACH STEP INDIVIDUALLY WITHIN THIS WORKFLOW.
Tip: Use down arrows and click F7 OR EXECUTE each of the 5 steps.
I do not know how to execute the steps individually nor do understand the tip. What are the 5 steps ? and is it a list one is looking at not OBJECTS? The tip indicates use down arrows and clicking f7 , but where is the list one should access and see and identify that there are 5 steps. I looked at the objects and I could not identify the 5 needed to be executed.
I think that one identifies a list at the Dataset for Analysis workflow and one by one selects from the list and executes each one of the steps one at a time.
Please can I be advised so that I can complete. I attach my file; the data structure I have has BABA for RTRT and ABAB for TRTR. [file name=FDA_RSABE_TemplateANGUS_.phxproj size=2749219]http://pharsight.com/extranet/media/kunena/attachments/legacy/files/FDA_RSABE_TemplateANGUS_.phxproj[/file]

[Linda Hughes]

Hello Angus,

 

I think the confusion is caused by there actually being more than 5 objects that need to be executed. See the screenshot at the bottom of the prior page, after step 8. On the left-hand side of the screenshot, the Data Link "5_Map your Data to Required Columns" is circled, and Step 8 is to execute that Data Link. For step 9, it just means to execute each of the objects under that Data Link, starting with "Merge Reference Name". So select "Merge Reference Name" in the Object Browser, then select the Execute button, then select "Merge nseq", then Execute, and continue through the rest of the objects in the "Prepare Dataset for Analysis" Workflow. Or, after selecting "Merge Reference Name", you could also just use the down-arrow key to move through the objects and use F7 for executing. The main point is that you should execute each object individually rather than just selecting the Workflow "Prepare Dataset for Analysis" and hitting Execute.

 

Regards,

Linda Hughes

[Angus McLean]

Linda: Thank you; it is the source of confusion. I am intent on following the steps detailed .

Also I not so familiar with individual execution of steps.

 

So I will continue with the exercise to see if I can complete it.

 

Angus

[Angus McLean]

Linda: Thank you I did get the program to run and the ABE (average bioequivalence results were produced). In this case the ABE results were within the usual limits.{this is "dummy" data}.

 

I followed the procedure involving highlighting the Object "Final RSABE results"

 

After gong to the SETUP TAB and highlighting STEP 9 while executing I found that the program halted. The Objects in the Object browser were not flashing. I repeated this 3 times and I got the same result.

 

I could not get the program to complete and had to stop using "Task Manager"

 

I note from the text above 12 (Tip 1.3 indicates that Phoenix can stop at this stage.

 

Is there any information available on this problem and if it has been resolved.,

 

 

Best regards,

 

Angus

[Linda Hughes]

Dear Angus,

 

I'm not following why you are seeing STEP 9 as the final step in the Data Wizard object "Final RSABE results". I see "Step 10 Properties" on the Setup tab, for both the FDA Full Replicate and FDA Partial Replicate projects, and when Step 10 is selected before executing, the Data Wizard object should run to completion.

 

In any case, the problem has been resolved for the next release, Phoenix 1.4. All issues we found with executing these workflows were corrected for Phoenix 1.4. In addition, after the 1.4 release, we will supply RSABE templates and projects created with Phoenix 1.4.

 

Regards,

Linda Hughes

[Angus McLean]

Linda: I have been able to get to the end of the program. I have done this by looking less at the instructions and trying things on my own. I am still wondering exactly how I managed it.

 

I am thinking that the program has been updated and the instructions I have may not reflect exactly how you do work with the program.

 

I find ambiguity in the instructions and this may be caused by my lack of understanding of exactly how how the program works. I need more details. The document is not paginated so at Section 11 after expanding the workflow and when you turn the page you can see a referencing highlighting the last step 9 properties.". I have been able to do this now, but I do not know exactly how I managed it. There is ambiguity on exactly what you do in the steps.

 

I need to revisit this and take detailed screenshots as I work.

 

I am wondering when the new version will be released (v1.4) . It might be quite a while,

 

Thanks for your comments,

 

I will keep working.,

Angus

[Angus McLean]

Linda

After mapping the fully replicated data to “map your data to required columns” within “Prepare Dataset for Analysis” Workflow and executing at “set up”, I checked the results and I see in “Results” that the data has imported and was now black in color (not pink). In the results Tab for the result worksheets within “Prepare Datasets for Analysis I noted all the remaining numbers in the sheets were pink.

“Merge Reference name worksheet” is next for set up and after execution I checked the results and I see the numbers in black (previously they were in pink). On checking remaining other sheets (12) in “the Prepare Data Set for Analysis” Workflow I noticed they had all changed color from pink to black without any further execution on my part. It seems they had all executed.

Therefore I proceeded to ABE: I found to get that to work I had to expand this ABE Workflow by double clicking on it prior to individually executing the Objects within.{ It did not work by highlighting “ABE” object and executing as as per direction I the Guide entitled “How to Execute FDA RSABE Template”}.

At 11 I found that by double clicking on RSABE Workflow Object it takes me to set up and I can highlight “Step 9 Properties” (and execute while Step is highlighted to get the required result).

For the Final Step I expanded the workflow “Final Conclusion Tabulation” and executed the individual objects and executed them in an order I considered to be judicious. So that worked too.

So these are my findings,

Thank you for your help

Angus

[Linda Hughes]

Hi Angus,

 

We actually on working on the final stages of the 1.4 release. We are estimating an August release as of now.

 

After release, we could try to look into your comments about the documentation for the RSABE workflows. Having page numbers would make is easier to communicate about these documents and to answer questions.

 

Linda

[Wu Liang]

Dear All: Could anyone creat a link to the recorded webinar or the slide deck of  "How to Execute the FDA RSABE Template from Phoenix 1.3" ? Many Thanks~

[Simon Davis]

Hi Liang,

 

Simply go to http://www.certara.c.../results/query/and type RSABE in the sesarch box, or if it works go to the link below....

 

  Simon

 

https://certara.webe...RecordingURL.do

[Simon Davis]

Tomorrow, (25th Sept 2018) there is a free Webinar:  Learn how reference-scaled average bioequivalence (RSABE) templates can save time and increase users’ productivity. Register here: http://bit.ly/2nSFjsl

 

  Simon.