Method Development and Validation

Advanced methodologies. On time performance.

PharmaNet offers custom method development, assay validation, and sample analysis using state-of-the-art LC/MS/MS and immunochemistry assays and a team of detail oriented scientists. Our staff has developed LC/MS/MS methods including routinely quantifying levels below one pg/ml. We have methods for multiple analytes, metabolites, prodrugs and light- and temperature-sensitive compounds. PharmaNet scientists also have considerable expertise in developing methods for immunoassays (ELISAs and other ligand binding assays) and cell-based assays.

Because we recognize the need for rapid method development, sample analysis can typically be performed within a few days. We work closely with your scientific staff to validate methods, and to ensure that assays have demonstrated linearity, recovery, reproducibility, specificity, accuracy, and stability under all conditions. All PharmaNet method validations are performed according to Good Laboratory Practices (GLP), and guidance from other regulatory agencies, and your company’s SOPs.