Bioequivalence and Bioavailability Forum

Dear All,

Could anyone please help me with guidelines for statistical analysis on the Invitro microbial kill rate. I didn't find it on the FDA website.

As per the product guidance Dexamethasone & Tobramycin we need to calculate 90% confidence interval for test and reference.

For the raw data having time point and kill rate do we need to find any parameter (PK/PD)?

Methodology for statistical analysis (like ANOVA or other test)?

This is the first time I am involved in this type of analysis.


Please help with this.

Thanks in advance.