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Our in vivo PK expertise makes us the partner of choice for global pharma companies, biotech and research organisations. We provide all aspects of in vivo PK support, from study planning to analysis and report writing. We can also carry out pre-formulation work. Our analytical method development tools include state-of-the-art triple quadrupole and high-resolution mass spectrometry (HRMS). Bespoke services are available as a comprehensive development program, a full-service single-study package, or as a stand-alone service.

Our in vivo PK studies in rodents can be adapted to all standard routes of administration and any dosing regimen with blood or plasma collection and tailored to include a comprehensive range of tissue harvesting. In addition to fast screening PK studies, such as cassette co-dosing studies, we can also conduct definitive PK evaluation and perform metabolite identification for non-labelled material.

The team uses HRMS and radio profiling methods with fraction collection to conduct mechanistic in vivo experiments to determine a drug’s absorption, biodistribution, and elimination mechanisms. IRBM can support CSF and bile collection in rodents and blood sampling from the hepatic portal vein in rat models. In-life experiments on larger species (i.e., Dog, Minipig, and NHP) are conducted by fully AAALAC accredited external partners.

The PK/PD Bioanaytics team provides support for targeted biomarker analysis for both efficacy (Predictive, Pharmacodynamic, and Prognostic Biomarkers) and safety markers. This includes metabolomic biomarkers, based on the analysis of intermediate metabolites and products of metabolism and  proteomic or protein biomarkers from the analysis of the protein profiles.

The bioanalytical team handles all types of drugs and biomarkers, from small molecules to complex proteins and at all stages, from sample preparation (PPT, SPE, LLE, IP) to final analysis (qPCR, LBA, MS/MS, HRMS).  Pharmacokinetic parameters are routinely calculated using established non-compartmental methods.

In addition to PK and mechanistic in vivo studies, the team routinely conducts PK/PD, efficacy studies, as well as all the required PK studies to provide essential and comprehensive information to determine dose range finding (DRF), maximum tolerated dose (MTD), no effect levels (NOEL) and encompass dosing regimens from acute (single dose) to chronic (multiple doses).




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