Validation of software for BE [🇷 for BE/BA]

posted by Helmut Homepage – Vienna, Austria, 2016-08-26 13:20 (3094 d 17:12 ago) – Posting: # 16582
Views: 5,096

Salam Mahmoud,

❝ […] our local regulatory authority […] want a validation proof for that package and program.


Understandable after the Kinetica-disaster (which was very popular in the Middle East).

❝ Can anyone of our forum experts advise me on how to supply the proof for that request.


I suggest to compare bear’s results with the ones in other software packages. We published two papers on the topic in order to support users in validation.1,2 Following the PMC-links in PubMed the reference datasets are available.

Good luck!


  1. Schütz H , Detlew Labes D , Fuglsang A. Reference Datasets for 2-Treatment, 2-Sequence, 2-Period Bioequivalence Studies. AAPS J. 2014;16(6):1292–7. doi:10.1208/s12248-014-9661-0. PMID 25212768. [image] free resource.
  2. Fuglsang A, Schütz H , Detlew Labes D . Reference Datasets for Bioequivalence Trials in a Two-Group Parallel Design. AAPS J. 2015;17(2):400–4. doi:10.1208/s12248-014-9704-6. PMID 25488055. [image] free resource.

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

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

Complete thread:

UA Flag
Activity
 Admin contact
23,380 posts in 4,914 threads, 1,665 registered users;
44 visitors (0 registered, 44 guests [including 8 identified bots]).
Forum time: 05:33 CET (Europe/Vienna)

When people learn no tools of judgment
and merely follow their hopes,
the seeds of political manipulation are sown.    Stephen Jay Gould

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5