Bioequivalence and Bioavailability Forum • Phoenix 6.3 templates Reference Scaled ABE

AngusMcLean
★★

USA,
2014-03-11 01:53
(4061 d 07:50 ago)

Posting: # 12588
Views: 8,375

Phoenix 6.3 templates Reference Scaled ABE [Software]

i was reading the post from 3 months ago on the Pharsight Forum and I noticed below.

"The Phoenix WinNonlin software provides a BE module to perform average bioequivalence but this module is not currently designed for a complete RSABE analysis. However, RSABE can be performed in Phoenix WinNonlin 6.3 using reusable template projects and workflows for both EMA and FDA approaches. These template projects require minimal input from the user in order to be used with any input dataset from a replicated 3-period or 4-period crossover design. These Phoenix template projects are available for free download and the objective of this webinar is to demonstrate how they work."

I wonder if the FDA approach has been evaluated in comparison with SAS? How about dropout subjects? I thing there was a progesterone example from the FDA and it used SAS code, but I do not remember if input data was provided.

ANGUS

Edit: Category changed. [Helmut]

Helmut
★★★

Vienna, Austria,
2014-03-11 02:35
(4061 d 07:08 ago)

@ AngusMcLean
Posting: # 12589
Views: 7,651

PHX vs. SAS: RSABE

Post reply

Hi Angus,

❝ I wonder if the FDA approach has been evaluated in comparison with SAS?

Yes.*

❝ How about dropout subjects?

No problem.

❝ I thing there was a progesterone example from the FDA and it used SAS code, but I do not remember if input data was provided.

The FDA didn’t publish example data sets – only the SAS-code. Therefore, in validating the templates we used the data sets published by the EMA. You can download both in Excel-format here.

4-period 2-sequence (RTRT | TRTR) fully replicated, imbalanced (77 subjects), incomplete (missing periods: one period in six cases, two periods in two cases).
3-period 3-sequence (TRR | RTR | RRT) partial replicate, balanced (24 subjects), complete (no missing periods).

Results of both in PHX6.3 matched the ones obtained in SAS9.2. Additionally I removed period 3 of subject 24 in the second data set in order to get an incomplete design. Again, same results in PHX and SAS.

Henry A, Schütz H, Hughes L, Davis S. Performing Reference-Scaled Average Bioequivalence (RSABE) in Phoenix^® WinNonlin^®. AAPS Annual Meeting and Exposition; 2013:Poster T2350. doi:10.13140/RG.2.1.1008.0800. free resource.

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Helmut Schütz

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AngusMcLean ★★ USA, 2014-03-11 15:48 (4060 d 17:55 ago) @ Helmut Posting: # 12598 Views: 7,220	PHX vs. SAS: RSABE Post reply
	Thanks Helmut: I will try this out and see how it works. There should be quite a bit of interest in this work, I imagine. Angus

SDavis
★★

UK,
2014-04-23 14:54
(4017 d 19:49 ago)

(edited on 2014-04-24 12:36)
@ AngusMcLean
Posting: # 12875
Views: 6,989

PHX vs. SAS: RSABE templates

Post reply

this FAQ from that webinar;

http://www.certara.com/images/uploads/files/QA_RSABE_Webinar_Dec2013.pdf

and link to the forum post which discusses the templates should help;

http://www.pharsight.com/extranet/index.php?option=com_kunena&Itemid=55&func=view&id=2101&catid=46#2101

NOTE you will need to login to this forum to view this post, registration is free but do check your junk mail folder for the activation email!!!)

(they included some executed SAS results that you can view as well to see that they match as well as one of the functions of Connect which is to Execute external software like SAS or R remotely)
Simon

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