Non-Regulated Bioanalysis
Comprehensive Bioanalytical Services for Non-Regulated Studies
We provide a rapid fit-for-purpose bioanalytical service for non-regulated in vitro and in vivo studies, undertaking quantitative LC-MS/MS analysis of drugs, metabolites and biomarkers in a range of matrices, including plasma, blood, urine, bile, tissue homogenates and in vitro samples.
Key Services:
- Comprehensive bioanalytical services for both regulated and non-regulated studies
- Rapid, fit-for-purpose quantitative LC-MS/MS analysis for in vivo studies
- Expertise in challenging peptide drug analyses (pg/mL LLOQ)
- LC-MS/MS quantitation of drugs, metabolites, and biomarkers across a range of species
- Discovery PK, PKPD, and exploratory toxicology assessments
- Expert troubleshooting skills to resolve bioanalytical issues
- Complex analysis including unusual matrices, conjugates, peptides, and multi-dimensional methods
- Tailored approach to methodology and reporting
Tailored bioanalytical testing for late-stage, non-regulated drug studies across multiple matrices.
Applications: Our services support early preclinical and clinical studies, enabling the rapid progression of drug programs by providing critical pharmacokinetic data. Non-regulated bioanalysis is typically performed in three species with 4-6 animal studies in the program, contracted as individual FFS projects over 6-12 months.
Instrumentation: We utilize a range of advanced technologies, including:
- LC-MS/MS systems (Waters™ Xevo TQ Absolute, SCIEX™ TQ 6500+)
- UPLC and HPLC systems (Waters™ Acquity UPLC, Agilent 1290)