To the great chagrin of hard-core pharmaceutical scientists, the regulatory guidelines for safety assessment leave little room for experimental innovation; species, treatments, administration and exposure are necessarily normalized to facilitate the interpretation and comparison of data within an increasing dataset.
Although the requirement for structure is completely justified, experienced safety pharmacologists often encounter the unexpected, handing in more questions than answers. Innovative physiologists and pharmacologists rise to the challenge of designing out-of-the-box, inventive studies with new endpoints, novel routes of administration, or pioneering models.
These innovations are completely necessary; unique compounds are discovered every day, that work through a variety of mechanisms, in models –and ultimately, patients- which present unique pathophysiological profiles. A compound’s efficacy or safety in a standard, healthy animal study could be mis-translated into disastrous clinical predictions.
Hence the need to customize every preclinical assay, thoroughly for discovery-phase investigations, or within the limits imposed by current guidelines for GLP-compliant studies, in order to maximize the predictivity of the studies. Ranges in concentrations, varied formulations, special cells and animal models, adapted routes of administration (or co-administration), specific functional endpoints, are all elements of a successful study which deserve consideration, for each compound, all the time. The outcome can be turned from “Inconclusive” to a resounding conclusion when team members are willing to go the extra mile, think outside the standard protocol.
Contact us to learn more on how IPST scientists customize every and all study designs to maximize your ROI, both scientifically and strategically.