Bioequivalence and Bioavailability Forum • Beyond the abstract & Kinetica

Beyond the abstract & Kinetica [Design Issues]

posted by Helmut – Vienna, Austria, 2015-02-11 15:27 (4146 d 20:18 ago) – Posting: # 14404
Views: 16,881

Hi ElMaestro,

❝ [humor]

❝ Because they used Kinetica :crying:

❝ [/humor]

Nope: “For the statistical analysis of data derived from this in vivo study; general parametric procedures for linear models (normal theory) were used and an analysis of variance (ANOVA) was performed using the statistical application Phoenix™ WinNonlin^®; version 6.3; 2013.”

BTW (Dec 24 2014, source)…

Kinetica 5.1 SP1 has been released
Thermo Fisher Scientific is very pleased to announce the release of Kinetica 5.1 SP1. Kinetica now supports unbalanced data sets for two period, two treatments, two sequences Bioequivalence studies. This issue was first reported in the Journal of the American Association of Pharmaceutical Scientists (AAPS) article entitled, "Reference Datasets for 2-Treatment, 2-Sequence, 2-Period Bioequivalence Studies. The article described the validation of software used to assess bioequivalence and reported that results from Kinetica software differed from other similar software when unbalanced datasets were used (results for balanced datasets were consistent across all of the software packages). Please find the […] issues fixed below:
Issue Description
Incorrect equations used for bioequivalence determination in unbalanced datasets – Point Estimate and 90% Upper and Lower limit calculation for Latin Square 2 Formulations statistical analysis.

Do you expect that Thermo fixed the bug for parallel designs as well? I don’t.

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Helmut Schütz

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Complete thread:

Montelukast BE study rahul dixit 2011-01-03 15:17 [Design Issues]
- Montelukast BE study bjkim97 2011-01-06 06:45
  - Opinions ... d_labes 2011-01-07 13:51
    - Opinions ... bjkim97 2011-01-11 06:47
  - Montelukast BE study joy_fm 2015-02-05 13:10
    - MHRA’s PARs Helmut 2015-02-05 13:24
      - MHRA’s PARs joy_fm 2015-02-10 17:38
        
        CV from the CI Helmut 2015-02-11 02:05
        
        CI2CV d_labes 2015-02-11 09:16
        
        Beyond the abstract Helmut 2015-02-11 13:01
        
        Beyond the abstract ElMaestro 2015-02-11 13:36
        
        Beyond the abstract & KineticaHelmut 2015-02-11 14:27
        
        Beyond the abstract & Kinetica d_labes 2015-02-11 14:59
        
        Partial credit ElMaestro 2015-02-11 15:49
        
        Partial credit ioanam 2016-01-22 14:17
        
        Partial credit ElMaestro 2016-01-22 14:58
        
        Partial credit Helmut 2016-01-22 15:06