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Biocompatibility evaluation of gas pathways

#1
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.
 
Elsmar Forum Sponsor
#4
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
Staff member
Moderator
#5
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?
 
#6
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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