Bioanalytical Method Validation
Our bioanalytical staff offers rapid method development and testing of LC-MS/MS assays for pharmaceutical/investigative compounds and their metabolites in human and/or other animal routes. We will work on your project to efficiently develop a sensitive, robust and cost-effective method to suit your particular study.
VxP Pharma can provide you with custom method development and tech-transfer services, as well as existing methods for sample analysis to accommodate your specific bioanalytical needs. We specialize in developing and validating unique methods for chiral separations and drug-drug interactions. Our bioanalytical laboratories are outfitted with the latest testing equipment to support the simplest methods/pilot studies to fully integrated clinical programs.
In vitro Services
Our qualified staff and regulatory support personnel can provide you with qualitative/ quantitative testing and data interpretation to address a variety of regulatory guidelines throughout the drug development process, including testing for metabolic, toxicokinetic, and bioanalytical investigations. Our in vitro studies can be conducted with both cold and radiolabeled test materials as required.
- Drug-drug interactions (CYP450 inhibition/induction)
- Drug absorption and kinetics (Caco-2 cells)
- Species variation in metabolism (hepatocytes/microsomes)
- Influx/efflux transporters
- Protein binding studies
- Ex-vivo induction studies
- Dermal absorption studies
- Metabolite stability profile and identification
- Aqueous solubility
- Cell viability (cytotoxicity) and proliferation studies
- Enzyme assay development
All services can be provided to meet GLP/GMP guidelines (or non-GLP as requested) for both small molecule and large molecule programs. Additional support is also included by our full service Analytical Chemistry Laboratory and Quality Assurance Department.
Our state-of-the-art labs are staffed by some of the best trained and most experienced subject matter experts in the field.