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Dear All,
Currently I am working on Nasal spray study. As per FDA guidance for nasal spray 1999, the criteria for bioequivalence study is to calculate PBE and if PBE is less than or equal to thita (in vitro BE (upper) limit) then it is bioequivalent.
the formula for PBE is
{{Square of (Mean of T - Mean Of R)} + {variance of T -variance of R}}/Variance of R.
But here Variance of T and Variance of R means total variance that is calculated using 3 variability components which as per my understanding we have to calculate using method of moments.
Can anybody explain me how to calculate Var. of T and R in this situation.
Best Regards, Harshada Biostatistician, Wockhardt Ltd.
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