'Differences in Example and Excel Calculations
We are trying to produce an Excel file to calculate a population bioequivalence test as per the FDAs Budesonide Product Specific Guidance (PSG), which can be found at https://www.accessdata.fda.gov/drugsatfda_docs/psg/Budesonide_Inhalation_Sus_20929_RC_09-12.pdf. How to perform the calculation and an example is given from page 5 onwards.
We have been able to replicate the calculations in Excel , however the results for the constant and reference scaled intermediate parameters obtained using Excel differ ever so slightly to those the FDA provide as the example (page 14) often at the low decimal places see table below Excel vs PSG values. We have double checked (including performing some of the calculations in Minitab 20, where you get same result as Excel) and the equations/formulae appear correct, just not the output. I suspect that the FDA may have used SAS to calculate these and therefore it may be a difference in how Excel and SAS do calculations that may be causing these minor differences.
Can anyone help or confirm if my suspicions are correct?
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