The high cost of pharmaceutical development today, driven by constantly evolving pathologies and healthcare needs, pushes drug developers to pursue operational improvement while striving concurrently to raise quality and adhere to regulatory standards. These are complex challenges when the stakes include an estimated $1+B needed to bring each new drug to market. With a high proportion of this cost attributed to clinical trials, available efficiencies may be overlooked in the pre-clinical stage, where outcomes can have a substantial effect on the design and efficacy of human trials. Ample opportunities to decrease capital outlay, increase study quality, and satisfy the 3R principle (Reduce, Refine, Replace), exist at the pre-clinical stage.
Integral to successful drug development, most pharmacokinetic (PK) and toxicokinetic (TK) studies are still carried out with the traditional manual sampling method, which involves periodically restraining an animal to dose and then draw blood at planned time points. With the stress involved, extensive human interaction, and manual processing, the manual method has not evolved to today’s stated challenges. The result is a pre-clinical trial that is more expensive, yields less reliable samples, and uses more animals than automated in vivo sampling. The automated sampling method offers the development community resource reduction and process refinement.