Modified chi square statistic test (mCSRS)

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I think this is very broad yet specific question, :eek::confused:



1) we have to compare the test and reference product for multiple (related)parameters; and we have come across this tool of mCSRS
2) are these similar/superior to that reference scaled average BE approach?


A) Application of the modified chi-square ratio statistic in a stepwise procedure for cascade impactor equivalence testing.
most of the points are self explanatory. (I see that denominator of the calculation/equation is changed/modified ! wrt calculation of mCSRS!)

B) A Step-wise Procedure for Population Bioequivalence (PBE) Analysis of Orally Inhaled and Nasal Drug Product (OINDP) Bioequivalence Studies


REFERENCE :-
Implementation of a Reference-Scaled Average Bioequivalence Approach for Highly Variable Generic Drug Products by the US Food and Drug Administration
 
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