Pharmacokinetic (PK) and toxicokinetic (TK) analyses are key activities of early drug development. These studies can be exploratory, or can be more extensive and formalized requiring GLP compliance. Thoroughly understanding the DMPK of a potential clinical candidate can have a huge impact on the success of a drug discovery program.
PK and TK studies provide useful and required information that informs no effect levels (NOEL), human equivalent doses (HED), and pharmacokinetic/pharmacodynamic (PK/PD) drivers. Carrying out PK studies enables the determination of PK parameters such as AUC, clearance, volume of distribution, half-life, Cmax, and Cmin.
Pacific BioLabs’ integrated toxicology and bioanalytical services can seamlessly perform in-vivo sample generation as well as bioanalysis. PBL can conduct PK and/or TK studies in most rodent species, and has the instrumentation and expertise in its bioanalytical lab to provide rapid and sensitive drug concentration determinations from a variety of matrices.
PBL has experience working with many biomatrices, and extraction conditions will be optimized to provide reproducible and robust methods. Exploratory PK with bioanalysis can be implemented simultaneously and completed rapidly in many cases. For GLP compliant TK studies PBL provides the technical and regulatory (QA) expertise to ensure method validation protocols, validation reports and analytical standard operating procedures (SOPs) are all in compliance with current GLP requirements.
Test Categories and Bioanalytical Lab Services
- Pharmacokinetics (PK) Studies
- PK Sample Analysis
- Toxicokinetics (TK) Studies
- Mass Balance
- Tissue Distribution
- Bioequivalence (formulation support)
- Guinea Pig
Routes of Administration
Read More About Pharmacokinetics, Pharmacodynamics and Toxicokinetics Testing
PBL’s Preclinical Toxicology Booklet
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