Locke's method for bioequivalence evaluation of topical dermtologic corticosteroids

Phoenix Certara Forums Phoenix WNL basics
1

Hello everyone,
I have question about Locke’s method for bioequivalence evaluation of topical dermtologic corticosteroids that is suggested by FDA. It described in the guidance (check attached file) in appendix V on pages 38-39. Maybe someone had experience with it? How it can be realised in Phoenix Winnonlin?

Best regards, Veronika.

Topical_dermatologic_corticosteroids___1995.pdf (2.59 MB)

2

Hi Veronika, this methodology isn’t currently supported in Phoenix as an ‘off the shelf’ function, but is already noted as something our users are interested in;

QC4871 – “Confidence intervals (CI) according to Fieller’s theorem or Locke’s Method (or Bailer-Satterwaite)”

. However it could be currently written/run as a workflow within Phoenix if that is of interest to you?

Simon.

3

Hello Simon, thank for your reply.

If it could be written/run as a workflow within Phoenix, it would be interesting for me how to make it. Look forward to your reply.

Veronika.

4

Hi Veronkia,

Here is an example project; it’s not an ‘official’ solution as it hasn’t been QC’ed etc but it may help as a basis for your workflow.

SImon.

Locke.phxproj (690 KB)

5

Thank you so much for your help, Simon!

Best wishes, Veronika.