The primary objective of safety pharmacology studies is to identify potential adverse functional effects of a compound on the central nervous, respiratory, or cardiovascular systems.
Like many areas of drug development, safety pharmacology is a rapidly progressing industry segment. The technologies and tools available to conduct these studies are evolving and expanding regularly. A critical—and quickly advancing—element of safety pharmacology studies is telemetry, typically used for cardiovascular monitoring, in which surgically implanted devices wirelessly broadcast key physiological signals to data collection systems for analysis. This approach allows for the gathering of vital cardiovascular data from unrestrained animals, thereby allowing for the detection of subtle changes in these critical endpoints that might otherwise be masked by the physiological effects of handling.
The gold standard for cardiovascular evaluations remains the standalone crossover design. However, as situations allow, these endpoints can be incorporated into toxicology studies to reduce animal usage, compound needs, and ultimately cost. Further, with the increasing number of biologics in development, a crossover design may not be appropriate and modifications must be made to avoid confounding factors such as antidrug antibodies. In these cases, new software tools available at MPI Research are able to provide more options with regard to study designs, allowing greater customization based on the characteristics of each individual compound, while promoting the highest standard of animal care.
MPI Research scientists apply their decades of experience and innovative on-site technologies to provide integrated safety pharmacology assessments, from cellular to whole-animal studies, and conduct experiments to seamlessly evaluate functional safety within the context of traditional toxicology studies. To optimize safety pharmacology testing, Sponsors should collaborate with their Study Directors to develop the most effective, practical, and cost-efficient study design for their compound.
To see a complete overview of safety pharmacology capabilities at MPI Research, click here.