Inflation of the TIE as well [RSABE / ABEL]

posted by Elena777 – Belarus, 2020-03-10 19:28 (465 d 08:19 ago) – Posting: # 21235
Views: 9,573

Dear Helmut, still have some doubts regarding decision scheme.

As per you comment:
» you are modifying the common decision scheme. Why?

It seems not only I would like to modify a decision scheme. I saw the following conclusion in the PAR (https://db.cbg-meb.nl/Pars/h116289.pdf).

Conclusion on bioequivalence study
The reference product was found to be highly variable for Cmax with an intra-subject variability greater than 30%: the intra-individual coefficient of variation was 41.62%. Widening of the acceptance intervals for Cmax was allowed but, based on the study results, proved not to be necessary. The 90% confidence intervals calculated for AUC0-t and Cmax are within the bioequivalence acceptance range of 0.80 – 1.25. Based on the submitted bioequivalence study Atorvastatine STADA is considered bioequivalent with Lipitor.


As I understand, they did not use the decision scheme described in the lecture. Otherwise it was obligatory for them to modify CI for Cmax. But they just stated that "widening of the acceptance intervals for Cmax was allowed but, based on the study results, proved not to be necessary".

So, how do you think what decision tree was used in that study?

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