Over the last year, the BiocompCHATibility Podcast hosts have been compilingquestions asked by our listeners and training series attendees. In this episode, wewill answer your frequently asked questions about all things biocompatibility—andno, we did not answer why Don is funnier than Sheri (it is definitely a growthopportunity for her).Highlights include:The use of clinical data in the biological evaluationCompleting chemistry testing before in vitro/in vivo studiesGathering historic data -and how much is useful to the evaluationU.S. FDA and DBT (dose base threshold) valuesThe truth about “whole lifecycle” evaluation“I can certainly do a preliminary risk assessment and not have any extractablestesting because part of my plan might be to go do extractables testing; but thatdoesn’t mean I always need it.” – Don Pohl“If you have clinical data and you are doing a preliminary risk assessment toevaluate 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 tothe endpoint very specifically.” – Don Pohl“For manufacturing, I make sure to understand what was there and what wasn’tthere. Mapping the process out is important for the reader of the assessment tounderstand I have performed the evaluation of the manufacturing and any impactit has on biological safety.” – Don Pohl

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