Invitro microbial kill rate Stat analysis [Regulatives / Guidelines]

posted by MGR  – India, 2021-12-15 07:51 (415 d 11:07 ago) – Posting: # 22696
Views: 1,041

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.


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