## Validation of PhEq_bootstrap [Software]

Hi Rayhope,

» similar query received from agency for validation of PhEq results.

May I ask: Which one?

» Can you help me out with simple steps to do that. I dont know about programming or validation of software. I read all conversations related to your post, I came to conclusion that Validation of PhEq and BootF2CA is not at all my cup of tea.

OK, understandable. You have to hire a [ contract killer ] consultant knowledgeable with and – preferably – solid background in ƒ2 comparisons and bootstrapping.

» But need to reply on Agency query how to proceed.

Maybe it is sufficient to point to this* goody? Luther Gwaza works for the WHO and Alfredo García-Arieta for the Spanish agency AEMPS. He is also member of the CHMP’s Pharmacokinetics Working Party. A quote from the paper’s Discussion:

[…] the results demonstrate the adequacy of PhEq Bootstrap and Bootf2bca software to replicate the observed results (Shah et al., 1998). As expected, the 90% CI were more similar among the software considered when the number of bootstrap replicates increased, although the observed differences could be explained by the seed number considered by each computer and the computer processor. The external validation shows that similarity conclusion for each comparison was irrespective of the software considered.

As shown in this post, in the current version of bootf2BCA a fixed seed of 100 is used by default and documented in the output. Hence, results are reproducible – independent from the machine and the operating system.

» Also let me know if you can provide SAS code for bootstrap […]

Sorry, I’m not equipped with ‘’.

• Noce V, Gwaza L, Mangas-Sanjuan V, García-Arieta A. Comparison of free software platforms for the calculation of the 90% confidence interval of f2 similarity factor by bootstrap analysis. Eur J Pharm Sci. 2020; 146: 10529. doi:10.1016/j.ejps.2020.105259.

Dif-tor heh smusma 🖖
Helmut Schütz

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