Dear all How to perform the performance qualification for SAS and Winnonlin. i searched the literature in health canada guideline having subject concentration, PK parameters and statistical output but in statistical out is showing some typo error so i am unable to prove with health canada data for statistical analysis. Kindly suggest any published literature or any other source to perform the performance qualification for Statistical analysis. thanks in advance.
Karthik, some people use the data from the Examples guide. We of course also have a Validation Suite for Phoenix WinNonlin. http://www.certara.com/products/pkpd/phx-wnl/phx-wnl-val/ If you want data directly from the Regulatory organisations then try a search for “validation sets” on BEBAC; brought me quite quickly to these sets from the EMA; Bioequivalence and Bioavailability Forum • Average scale BE study But if there is really a typo on the Canadian set - try contacting them to get this changed /updated. Simon PS in fact your exact same question re Canadian data was discussed here …forum.bebac.at/mix_entry.php?id=5001#p5605 back in 2010