Pharmacokinetic (PK) and Toxicokinetic (TK) analysis is an important aspect of drug development. These studies may be exploratory in nature or more extensive and formal. Understanding the bioavailability, exposure, half-life, clearance and metabolism of your drug may be the difference between success or failure in the clinic. Pacific BioLabs has integrated toxicology and analytical services departments that can coordinate the in-life and bioanalytical aspects of a PK study.
Pacific BioLabs operates GLP compliant systems and validated instrumentation. We have several LC/MS/MS systems as well as ELISA platforms to provide sensitive, high throughput evaluation of drug concentration in a variety of matrices. Stability studies and metabolite identification can be conducted to understand the strengths and liabilities of your compound.
We can quickly develop and validate a sensitive, accurate and robust PK assay in a number of different matrices from different species. We have experience working with plasma, serum, urine, CSF, and tissue. Our chemists will optimize the extraction conditions to provide a reproducible and robust method. Non-GLP exploratory PK assays can be implemented in a few days and use 4-6 reference standards, internal standard, and quality control samples. Pivotal GLP compliant Toxicokinetic studies require method validation protocols, validation reports and analytical SOP. We have the systems and Quality resources in place to guide your project, comply with the latest regulatory requirements and ensure high quality, timely data.