Pharmacology studies demonstrate the intentional drug-related effects on enzymes, receptors or other targets. The pharmacology of a drug influences preclinical species selection for some studies.
As needed, Preclinical GPS manages in vitro and in vivo pharmacology assessments to confirm intended pharmacological effects.
Secondary pharmacology studies evaluate the potential off-target or unintentional effects of a drug. These studies are important in predicting potential toxicities and demonstrating safety.
For small molecule drugs, Preclinical GPS manages in vitro screens of up to 90 enzymes and targets.
Safety pharmacology studies evaluate potential impact of new drugs on vital organ systems before first-in-human drug testing.
Preclinical GPS manages studies that evaluate in vivo effects on cardiovascular, respiratory, and central nervous systems, as well as in vitro effects on hERG channel. As needed, we also evaluate potential drug-related effects on gastrointestinal motility and kidney function.
How we help
We manage the outsourcing process for these studies using only reputable and experienced laboratories. The outsourcing process includes designing studies, generating requests for proposals, negotiating contracts, implementing studies, monitoring studies, reviewing data and preparing reports. Outsourced studies are supported by our proprietary project management processes to ensure on-time, on budget delivery.
We also author pharmacology sections of regulatory documents to support IBs, INDs, NDA, CTA, and BLAs.