INTERVIEW WITH ROGER HAYES
“ The conservatism will disappear; ”
I think microsampling will become absolutely routine.
Q
What are the benefits of microsampling?
Well if I didn’t say the three Rs I’d be frowned upon. So really the replacement, refinement and reduction of animals, that’s key. But there’s the quality associated with that, the better you can do serial sampling the better the quality of the data coming out of what you are analyzing. When you’re using fewer animals on study, and this is more strictly in the discovery and nonclinical space, everybody is happier. There is a cost reduction as well; in addition to getting the quality with a cheaper study.
Serial sampling has been taken as the gold standard for doing pharmacokinetic analysis,
there’s less variability when you’re taking blood out of the same animal, it’s also faster and you don’t have to wait as long to get that sample. However, with recent volumetric accurate devices that are around, like volumetric absorptive microsampling (VAMS), they can take samples of 10 µl, are much faster and cause less stress on the animals.
Certainly the accuracy there not only just improves the overall quality but also PK timing, trying to get a blood sample every 15, 30 and 45 min when you’re trying to warm an animal up to get the normal approach to bleeding can often leads to problems, for example if the animal squirms and you just can’t get the blood flow. So with new microsampling devices like VAMS, it just improves the overall quality of data and less animal stress.
Q How has the demand for microsampling increased in recent years?
Well, I would argue microsampling has always been there – any time that you can do bioanalysis with a little as possible sample and push detection limits, this has always been there. I think the industry and the buzzword of microsampling have been confused a little bit with the dried sample. In recent years the dried blood spots (DBS) seem to be the real push and at least microsampling is coming into the vernacular for bioanalysis. And really I think that DBS has its place with simplifying the sample shipments, the opportunity for home base sampling, pediatric trials and all of those kinds of things.
But microsamples have always been there. What has happened is that instead of doing 0.5 ml plasma aliquots of bioanalysis and fairly extensive concentration workflows to get the sensitivity we need, as the instruments got more and more sensitive this became 50 µl and now it is 5 µl.
Currently we’re doing nanoliters on platforms like the Gyrus workstation – so it’s evident that microsampling has always been there, the technology has just improved and has just gotten easier.
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