Biocompatibility evaluation of gas pathways

khann

Registered
Can anyone give ideas for evaluating the gas path in terms of biocompatibility evaluation regarding use of polar and non-polar solvents that would simulate drug contact? The device has a small chance of drug entering the pathway during use and FDA has asked this question. We did standard E/L with SO and NaCL. Use is less than 24 hours. Thanks for thoughts.
 

khann

Registered
Yes we did polar and non polar extractions and now FDA is asking how those solvents cover if drugs get into it. It is an emergency device so there is a remote chance that a little could get in there. Thanks
 

Ronen E

Problem Solver
Moderator
Yes we did polar and non polar extractions and now FDA is asking how those solvents cover if drugs get into it. It is an emergency device so there is a remote chance that a little could get in there. Thanks
Did you present an analysis of the relevant drugs, showing what their formulation is based on and how the solvents you used simulate them?
 

khann

Registered
Did you present an analysis of the relevant drugs, showing what their formulation is based on and how the solvents you used simulate them?
No. I didn’t write the submission. They called me in later. I can try that for the response. I can proabably come up with what might be given through it in an emergency. They did the standard polar and non polar. I think they need to do a semi-polar extraction as well. Thanks Ronen
 
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