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RegisterInvitro microbial kill rate Stat analysis [Regulatives / Guidelines]
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.
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.
—
Regards,
MGR
Regards,
MGR
Complete thread:
- Invitro microbial kill rate Stat analysisMGR 2021-12-15 06:51 [Regulatives / Guidelines]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Invitro microbial kill rate Stat analysis dshah 2021-12-15 11:36
- Invitro microbial kill rate Stat analysis MGR 2021-12-20 09:41
- Invitro microbial kill rate Stat analysis dshah 2021-12-20 12:17
- Invitro microbial kill rate Stat analysis MGR 2021-12-20 09:41
- Invitro microbial kill rate Stat analysis dshah 2021-12-15 11:36
Ing. Helmut Schütz