Posting: # 19869
We have questions on In-vitro Population BE study.
The approach used was the proc GLM for calculation MSW_R, MSW_T, MSB_R and MSB_R for parameters of D50 and Span to population bioequivalence.
We use standard algorithm for one life stage (m=1) as defined in draft budesonide guideline recommend sept 2012.
Now problem is our results does not matches with the sponsor results, when we calculated SD_R and SD_T for one life stage (m=1) from Proc GLM model.
There are large differences for the values of SD_R, SD_T and 95% upper confidence bound for linearized criteria of reference-scaled and constant scaled my approach, but the Geometric mean are very similar for both D50 and Span.
They have used the proc mean procedure and directly extracted SD_T and SD_R value and used all remaining calculation.
As mentioned in draft budesonide guideline, for data collected on one life stage (m=1), ignore E2, E4c and E4s and their corresponding H and U terms in the calculation.
Calculation formula for sigmaR and sigmaT (for more than one life stage (m>1)) are as below:
We did not found the algorithm with sigmaR and sigmaT calculation for one life stage (m=1). We have slightly modified SD_R and SD_T formula for one life stage (m=1) and remove (((m_R-1)*MSW_R)/m_R)) and (((m_T-1)*MSW_T)/m_T)) from above equation.
Modified equation are as below:
Here we are confuse with approach which is based on the draft guideline.
Can anybody comment of formula on SD_R and SD_T calculation for one life stage (m=1)?