The Mass Spectrometry Center's expertise and available applications in GLP-regulated bio-analysis for clinical studies are outlined below.
Good Laboratory Practice for Nonclinical Laboratory Studies (GLP) Regulations, 21 Code of Federal Regulations (CFR) Part 58 are regulations that pertain to all nonclinical laboratory studies submitted in support of a research or marketing application for a FDA-regulated product.
The Mass Spectrometry Center offers GLP-regulated bioanalysis for studies requiring this regulatory compliance.
- Analytical methods are validated according to FDA Guidance for Bioanalytical Method Validation
- LC-MS/MS based assays performed under GLP regulations
- Analysis of drug compounds and metabolites
- Method transfer from literature
- Custom LC-MS/MS assays for analytes of interest
- QA/QC surveillance and compliance