Pharmacokinetic (PK) studies are a key aspect of the drug development process. Data on drug Absorption Distribution, Metabolization and Elimination (ADME) are important elements for evaluation of efficacy and safety. Furthermore, PK-data provide essential guidance for identifying the appropriate dosing regimen.
IBR Inc. provides high quality analysis of Pharmacokinetic and Toxicokinetic samples derived from a variety of species like humans, non-human primates and rodents.
We are capable to perform analysis in different matrices such as plasma, serum, urine, saliva or any other body fluid. The development and validation of a PK assay can be challenging due to matrix-interferences and drug-drug interactions. Interfering matrix components such as lipids, serum proteins, anticoagulants, anti-drug antibodies or other factors such as ionic strength, pH or viscosity or other administered drugs, might result in unreliable PK data. Our scientists are versed in tackling these challenges. Furthermore, we are equipped with state-of-the-art technology, which reduces matrix-effects and increases assays robustness and the dynamic range.
We offer PK assay development, validation and sample analysis for any phase of the drug development process. The PK services of IBR Inc. are provided under the GLP and GCP quality standards in accordance with EMA and FDA regulations and following the ICH guidelines.