NO SUCH THING AS THE BEST TECHNIQUE
technique for clinical use will be different from the best practices for nonclinical studies.
“
...the ultimate, best suited microsampling ”
CONCLUSION AND THE (CLINICAL) FUTURE
At Janssen an evolution from regular sampling via non-CMS sampling to CMS sampling has taken place for non-GLP rodent studies over many years. Since last year CMS has become the method of choice for in GLP toxicology studies in the rat. Having gained experience with multiple techniques has provided us with the opportunity to adapt procedures to the needs of the project, while still having a clear preference for CMS. This has helped in discussions with project teams to adopt microsampling techniques in regulated studies, keeping in mind those samples may be needed for other purposes as well.
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Current practices continue to be evaluated, revised or changed if needed, based on new developments within and outside our company. Introduction of CMS in mouse and rabbit GLP studies is ongoing. Maybe this technique will be applied for studies with other species as well. Reasons for this are faster and easier sampling and/or reduced stress for the animal, e.g., for minipigs.
Except for some special studies, there are no concrete plans (yet) to apply CMS in clinical studies on a routine basis. There are two main reasons for this.
One is that the maximum allowed blood volume for humans is rather high compared to most of the pharmacokinetic needs. Therefore, the driver to reduce sample volumes is limited to a few situations in which there might be conflicts with required samples for biomarkers, safety parameters and interacting drugs, for neonatal or pediatric studies or for studies with patients that cannot afford to lose a lot of blood. Rather than restricting individual sample volumes, a compromise of parameters that have priority is often negotiated.
The second reason is that, although easy to learn, the procedure still requires some practice to be correctly applied. While that might be possible for phase-1 studies, arranging adequate training for all clinical sites in multi-site studies is quite challenging. Blood CMS is used for studies for which classical plasma sampling is not an option. Refinement of CMS procedures for plasma is required to pave the road to a general adoption of this technique in the clinic.
Some companies, e.g. Shimadzu Techno-Research, are working on this, but it may take quite some years before the use of microsampling in clinical trials reaches the level of practice and acceptance as is currently the case for non-clinical studies, while for those there certainly is room for broader acceptance as well.
In the end, it might well be that the ultimate, best suitable, microsampling technique for clinical use will be different from the best practices for non-clinical studies.
REFERENCES
1. Stieltjes H, Dillen L, Verhaeghe T. Non-capillary microsampling of plasma in rat and mice in support of GLP studies:
http://www.bioanalysis-zone.com/2015/03/16/non-capillary-microsampling-of-plasma-in-rat-and-mice-in-support-of- glp-studies/
www.bioanalysis-zone.com
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