GLP Bioanalytical Support

• GLP LC-MS and LC-MS/MS bio-analytical method development and validation for new drugs, metabolites, or generic drug assay.
• Quantitative analysis of active drug and its metabolites in biological samples (human and animal plasma, tissue, urine, bile, and feces) using protein precipitation, LLE, SPE techniques. Neurotransmitter and other polar compound analysis, Analysis of enantiomers of drugs or metabolites.
• Bioanalytical support for the evaluation of Pharmacokinetic/ toxicokinetic (PK/TK) properties including bioavailability/bioequivalence (BA/BE) sample analysis.

Non-GLP Bioanalytical Support

• Bioanalytical support for in vivo PK screening and terminal exposure studies (cassette dosing, microdosing, receptor occupancy, microdialysis)
• Bioanalytical support for in vitro screening (plasma protein binding, metabolic stability, PGP efflux, Cyp induction and inhibition, phenotyping)

Drug Substances Analysis

• Drug substance/drug product stability, degradant and impurity investigation
• Certificate of Analysis (COA), re-certification services for test substances and reference standards in both GLP and non-GLP projects
• Customized analytical service programs designed according to sponsor's specific requirements

Assay Methods List