Bioequivalence and Bioavailability Forum • PKanalix validation

mittyri
★★

Russia,
2022-12-07 16:51
(498 d 07:27 ago)

Posting: # 23386
Views: 1,776

PKanalix validation [Software]

Dear All,

I missed this abstract published during PAGE meeting: Validation of non-compartmental analysis (NCA) and bioequivalence results of PKanalix with respect to Phoenix WinNonLin and SAS.

Most interesting here is the set of the datasets they are using:

References:
[1] Schütz et al. “Reference Datasets for 2-Treatment , 2-Sequence , 2-Period Bioequivalence Studies.”, AAPS J. 16, 1292–1297 (2014).
[2] Fuglsang et al. “Reference Datasets for Bioequivalence Trials in a Two-Group Parallel Design.”, AAPS J. 17, 400–404 (2015).

Looks like that sets become to be state of the art! :-D

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Kind regards,
Mittyri

Helmut
★★★

Vienna, Austria,
2022-12-08 10:46
(497 d 13:32 ago)

@ mittyri
Posting: # 23391
Views: 1,375

PKanalix validation

Post reply

Hi Mittyri,

❝ Looks like that sets become to be state of the art! :-D

Makes sense. Currently replicate designs for reference-scaling are not implemented in PKanalix. Lixoft is working on it.
At the “Spring School with PKanalix™” (March 22–24, 2022) Lixoft pointed out that the paper of the usual suspects (doi:10.1208/s12248-020-0427-6) will be used in validation. ;-)

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

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