Sinclair Research Announces Successful Validation of GLP Safety Pharmacology Services
“Sinclair Research’s validated GLP safety pharmacology services provide drug developers with more research options,” Andy Brown, Sinclair Research’s Vice President of Commercial Operations said. “Sinclair Research is one of the only single-site CROs offering in vivo safety pharmacology studies, standalone or as part of an IND-enabling package, to help pharmaceutical developers assess the potential for adverse effects prior to first-in-human trials.”
Three pharmacological validation studies were conducted in Sinclair’s new purpose-built safety pharmacology telemetry facility. The new facility features an isolated layout to ensure the highest-fidelity data capture environment possible. The three studies, using well characterized hemodynamic, electrocardiographic and respiratory positive controls respectively, all demonstrated the ability to detect expected effects with an outstanding degree of fidelity.
“The GLP validation data generated in these positive control studies is among the highest fidelity I have analyzed for such core battery assessments,” said Dr. Michael R. Gralinski, CEO of CorDynamics. “We will be presenting this validation data at next week’s Safety Pharmacology Society Annual Meeting. It’s exciting to see our strategic partnership with Sinclair Research produce such a high-quality safety pharmacology service offering.”
About Sinclair Research
Sinclair Research, a nonclinical contract research organization (CRO), offers animal efficacy models, pharmacokinetics/pharmacodynamics evaluation, and IND-enabling toxicology and safety pharmacology research capabilities to support biopharmaceutical, animal health and medical device development programs. Sinclair is experienced in all research models and is the leading expert in miniature swine research. Built on more than 50 years of experience, Sinclair has emerged as a leader in diabetes, dermal, otic and animal health research services with streamlined quality systems supporting both VICH and GLP-compliant studies and SEND reporting with no backlog.
Founded in 2002, CorDynamics is the premier preclinical cardiovascular contract research organization (CRO) and consulting group focused on examining the cardiovascular effects of emerging drug candidates. The company is an industry leader in cardiovascular research and provides expertise, analysis and support with discovery and drug safety studies for more than 500 international biopharmaceutical clients.
Source: Sinclair Research