Bioequivalence and Bioavailability Forum

Dear Mr. Raja,

As per my knowledge, Regulatory looks for proper Installation, Operations and Performance of the software to assure that analysis has been carried out using valid procedures/equations/formulas.

I have faced audit from regulatory like- ANVISA, USFDA, FRANCE.
Definitely they may ask "Are you using validated software or validated programs?"

❝ We used to compare the result from winnonlin with results from excel (Validated Excel). I feeded the formula in excel which i have taken fromula from winnonlin help.

Instead of doing above exercise with another software-Microsoft Excel, you may validate your Procedures / programs by comparing your software results with reference data available in the published Books/Articles/guidelines.

For Example:
Health Canada Guidelines: "Guidance for Industry: Conduct and Analysis of Bio-availability and Bio-equivalence Studies - Part B: Oral Modified Release Formulations" contains complete data sets and its statistical analysis for Bio-equivalence. You may validate Bio-equivalence analysis of your software by comparing its output with this guideline output using data set given in it.

Same way, you may take data and its analysis from the book/articles and validate it with your software output

I have documented PQ of WinNonlin and few programs of SAS as per above example and it is accepted by regulatory auditors.


Thanks & Regards,
Nirali