Bioanalytical Services: Screening to Fully Validated GLP Bioanalysis
We offer GLP and non-GLP method development and sample analysis, with the rigor required to satisfy regulatory agencies. We routinely provide bioanalysis for ADME screening, preclinical pharmacokinetic (PK), toxicokinetic (TK) studies, metabolite identification, andGLP bioanalysisof plasma samples from human clinical trials. We can now offer radioactive drug detection. Our labs are equipped with 21 LC-MS/MS systems, allowing for analysis of thousands of samples a day. We can handle projects ranging in size from a few to several thousand samples.
Validation of bioanalytical methods follows the May 2018 U.S. Food and Drug Administration (FDA) “Guidance for Industry: Bioanalytical Method Validation” and the Absorption Systems Standard Operating Procedure (SOP) “Validation of Quantitative Bioanalytical Methods for Determination of Test Compounds and/or Their Metabolites in Biological Matrices.”
GLP bioanalysis also follows the FDA Good Laboratory Practices (GLP) regulations (21 CFR Part 58) and the OECD Principles of Good Laboratory Practice. In addition, all studies follow our own relevant SOPs.
Electronic Reporting and Documentation
LC-MS/MS data is generated using Analyst® Version 1.6.3 compliant with 21 CFR Part 11, and all customer reports are archived in a validated eQCM by Xybion database compliant with 21 CFR Part 11.