Immunobased assays such as ELISA or Western blots may also be used for targeted approaches, but will likely have more utility during
a clinical validation phase where much larger sample cohorts are used.
Not exact matches
But highly trained life scientists will still be needed for such tasks as late - stage development (ensuring smooth implementation of final
phase (III and IV)
clinical trials) as well as compliance with regulatory demands (so - called commissioning and
validation specialists), according to Croonen.
At Merck Frosst Canada, I have been an integral part of the discovery of a new molecule, the testing of its mechanism of action, the
validation of its safety and efficacy in
Phase IIb and III
clinical trials, the market approval of the resulting product, and the subsequent management of patients and their disease.
With respect to biomarkers, we believe our proteomic strategy [10], that did not require prior knowledge of which proteins might be present in the CSF, will accelerate the transition from a discovery
phase of candidate biomarkers, as described in this study, to full
validation for
clinical application.