MGR
★    

India,
2021-12-15 06:51
(37 d 14:23 ago)

Posting: # 22696
Views: 306
 

 Invitro 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.

Regards,
MGR
dshah
★    

India/United Kingdom,
2021-12-15 11:36
(37 d 09:38 ago)

@ MGR
Posting: # 22697
Views: 258
 

 Invitro microbial kill rate Stat analysis

Dear MGR!
Kindly find a Cross-discipline review by FDA cross-discipline review of FDA.
Kindly also review article- Clinical, Pharmacokinetic, and In Vitro Studies to Support Bioequivalence of Ophthalmic Drug Products.
Hope it may help.
Regards,
DShah
MGR
★    

India,
2021-12-20 09:41
(32 d 11:33 ago)

@ dshah
Posting: # 22702
Views: 179
 

 Invitro microbial kill rate Stat analysis

Dear Dshah,

Thank you for your reply.

Could you have any idea about the below question:

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

Thanks in advance,

Regards,
MGR
dshah
★    

India/United Kingdom,
2021-12-20 12:17
(32 d 08:56 ago)

@ MGR
Posting: # 22703
Views: 159
 

 Invitro microbial kill rate Stat analysis

Dear MGR!

For In vitro PD relationship- kindly view section 5 of Microbiology review. Also review- comparative article.
If you are interested for in-vivo PKPD and in vitro kill rate relationship, I am not sure but you can view some PBPK modeling which might be useful.
1. Ocular Physiologically Based Pharmacokinetic Modeling for Ointment Formulations
2. Application of Mechanistic Ocular Absorption Modeling and Simulation to Understand the Impact of Formulation Properties on Ophthalmic Bioavailability in Rabbits: a Case Study Using Dexamethasone Suspension
3. A whole-body physiologically based pharmacokinetic (WB-PBPK) model of ciprofloxacin: a step towards predicting bacterial killing at sites of infection.
Regards,
Dshah
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