Over the last year, the BiocompCHATibility Podcast hosts have been compiling questions asked by our listeners and training series attendees. In this episode, we will answer your frequently asked questions about all things biocompatibility—and no, we did not answer why Don is funnier than Sheri (it is definitely a growth opportunity for her).
- The use of clinical data in the biological evaluation
- Completing chemistry testing before in vitro/in vivo studies
- Gathering historic data, and how much is useful to the evaluation
- U.S. FDA and DBT (dose base threshold) values
- The truth about “whole lifecycle” evaluation
“I can certainly do a preliminary risk assessment and not have any extractables testing because part of my plan might be to go do extractables testing; but that doesn’t mean I always need it.” – Don Pohl
“If you have clinical data and you are doing a preliminary risk assessment to evaluate the safety of this device, it is general information and cannot be ignored. But, if you are going to use the data to offset the need for a test, it better speak to the endpoint very specifically.” – Don Pohl
“For manufacturing, I make sure to understand what was there and what wasn’t there. Mapping the process out is important for the reader of the assessment to understand I have performed the evaluation of the manufacturing and any impact it has on biological safety.” – Don Pohl
*Please note that the opinions discussed throughout the podcast are their own and do not reflect that of their current or former employers.
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