Bioequivalence and Bioavailability Forum

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!

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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. 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. free resource.