Bioequivalence and Bioavailability Forum

Public datasets [Software]

posted by Helmut  – Vienna, Austria, 2013-07-02 17:44 (4327 d 00:27 ago) – Posting: # 10914
Views: 42,474

¡Hola Elba!

❝ The preliminary review of my report indicates that I require verifying that my results are valid and it was recommended that I must demonstrate through a reference dataset the software performance.

OK, validation makes sense. I wonder whether your agency would have also asked you if you submitted data evaluated by commercial software.

You should quote the statement of bear’s site:

Validation: We have tested bear with one of BE dataset and found that all output results to be the same as those generated by commercial software (like NCA using WinNonlin and ANOVA with SAS).

Personally I use data sets from these references:

1. Sauter R, Steinijans VW, Diletti E, Böhm E, Schulz H-U. Presentation of results from bioequivalence studies. Int J Clin Pharm Ther Toxicol. 1992; 30/Suppl.1: S7–30.
   If you consider this reference too old, the same data are available in:
   • Hauschke D, Steinijans V, Pigeot I. Bioequivalence Studies in Drug Development. Chichester: John Wiley; 2007.
2. S-C Chow, Liu J-p. Design and Analysis of Bioavailability and Bioequivalence Studies. Boca Raton: Chapman & Hall/CRC Press;3^rd ed. 2009.
   They use this (in)famous data set:
   • Clayton D, Leslie A. The bioavailability of erythromycin stearate versus enteric-coated erythromycin base when taken immediately before and after food. J Int Med Res. 1981; 9(6): 470–7.
   The same data set is part of Pharsight’s Phoenix/WinNonlin standard installation.
   
3. Millard SP, Krause A, editors. Applied Statistics in the Pharmaceutical Industry. New York: Springer; 2001.

Ad #1: No idea how they evaluated the data; probably with SAS. Ad #2: SAS and Phoenix/WinNonlin. Ad #3: You can download Chapter 7; evaluation with S-Plus (scripts run on with some minor modi­­fi­cations). Maybe you should start with this one because it is the only one giving Cook’s distance plot (which is part of bear’s output). If you want to validate bear’s NCA as well, you have to go with #1 because it is the only one containing the entire concentration data.

—
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Helmut Schütz


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Complete thread:

• reference dataset elba.romero 2013-07-02 05:08 [Software] 
  • Public datasetsHelmut 2013-07-02 15:44
    • Public datasets yjlee168 2013-07-03 03:10
      • Public datasets elba.romero 2013-07-03 05:19
        • Public datasets yjlee168 2013-07-03 13:11
          • Challenging data sets Helmut 2013-07-03 16:32
            • Fantastic idea? ⇒ Challenging data sets yjlee168 2013-07-04 08:06
              • Fantastic idea! Helmut 2013-07-04 13:18
      • NIST; cross-validation Helmut 2013-07-03 14:28
        • NIST; cross-validation yjlee168 2013-07-03 23:47
          • NIST; cross-validation Helmut 2013-07-04 00:45
    • Public datasets elba.romero 2013-07-03 05:10
  • Eight Reference Datasets (2×2×2 ☑) Helmut 2014-10-06 02:24
    • What??? ElMaestro 2014-10-06 13:20
      • What??? Helmut 2014-10-06 17:08
        • What??? ElMaestro 2014-10-06 17:31
          • What the heck‽ Helmut 2014-10-06 19:05
    • link of electronic supplement material? yjlee168 2014-10-07 09:53
      • link of electronic supplement material? nobody 2014-10-07 10:59
        • Thanks! yjlee168 2014-10-07 11:35
          • Thanks! nobody 2014-10-07 11:44
            • Direct links & hint Helmut 2014-10-07 13:54
      • Replicated designs are relevant, too ElMaestro 2014-10-07 12:36
        • Replicated designs are relevant, too yjlee168 2014-10-07 13:00
          • RSABE: SAS and PHX/WNL only? Helmut 2014-10-07 14:47
            • for the future? yjlee168 2014-10-08 10:05
              • Star Trek: The Next Generation Helmut 2014-10-09 00:26
                • Star Trek: The Next Generation d_labes 2014-10-09 08:09
                • Star Trek: The Next Generation nobody 2014-10-09 08:23
                • Star Trek: The Next Generation yjlee168 2014-10-09 11:06
                  • Some comments ElMaestro 2014-10-09 11:52
                    • Some comments yjlee168 2014-10-09 12:18
                      • Proc MIXED - start value d_labes 2014-10-10 08:35
                        • Proc MIXED - start value ElMaestro 2014-10-10 11:44
                        • Proc MIXED - start value yjlee168 2014-10-11 21:09
                          • Proc MIXED - start value ElMaestro 2014-10-11 21:18
                  • Optimizer settings Helmut 2014-10-09 14:08
                    • Optimizer settings nobody 2014-10-09 15:32
                    • Optimizer settings yjlee168 2014-10-09 18:14
                      • FDA’s model… Helmut 2014-10-09 18:34
    • Just received a letter… Helmut 2014-11-03 14:54
    • 11 Reference Datasets (2-group parallel ☑) Helmut 2014-12-09 15:51