Pharmacokinetic and Toxicokinetic Bioanalysis
Pharmacokinetic (PK) bioanalysis is a critical aspect of drug development. PK studies may be exploratory in nature or more extensive and formal. Understanding the bioavailability, exposure, half-life, clearance and metabolism of a drug may be the difference between success and failure in the clinic. Pacific BioLabs provides in vivo dosing and sampling in multiple species, and can coordinate PK studies to perform all aspects including in vivo dosing and sample collection, PK bioanalysis, and preparation of PK data.
PK Bioanalysis at Pacific BioLabs
Pacific BioLabs’ analytical and bioanalytical laboratory contains GLP-compliant instrumentation, including multiple LC/MS/MS systems as well as ELISA platforms to provide sensitive, high throughput measurement of drug concentration in a variety of matrices.
PBL has great expertise in the development of analytical methods and can quickly perform bioanalytical method development and validation of sensitive, accurate and robust PK assays. PBL’s chemists have experience working with plasma, serum, urine, CSF, and other tissues, and will optimize the extraction conditions to provide a reproducible and robust method. PBL has numerous temperature controlled and monitored chambers to properly store sensitive samples prior to analysis. Method validations typically include an assessment of pre-preparative stability to demonstrate that drug residues in tissues are stable over the course of the study.
Pharmacokinetic/PK analysis using LC/MS/MS
Pacific BioLabs has over 25 years of experience in bioanalysis using LC/MS/MS for preclinical and clinical samples. We have supported LC/MS analysis for clinical trials from Phase I through Phase IV. These trials spanned multiple patient populations and clinical sites over several years. We have even conducted bridging studies when our clients modified their therapeutic product midway through clinical trials. Regarding preclinical samples, we have experience with multiple animal species including rodents, non-human primates and other large animals.
Pharmacokinetic Studies Utilizing ICP-MS
For compounds containing metals, ICP-MS may be used to perform PK bioanalysis. ICP-MS has the benefits of low detection levels (as low as ppb) and good specificity. Many new drugs are metals-based where the drug’s activity is dependent on the bioavailability of the metal. So whether your metal-based drug reaches its target through the blood or being absorbed into the skin, ICP-MS may be an excellent choice to measure the kinetics of your drug.
Other drugs may contain metals in their formulation: often these are carried over from the synthetic production of the drug. Copper, platinum, palladium, and cobalt are just a few examples of metals that are commonly detected in drug formulations. Whether you need to determine the level of a specific metal in your formulation, screen your drug for multiple metal residues, or measure the tissue levels for a metal following dosing, Pacific BioLabs can develop and perform the ICP-MS method to meet your needs.
Available PK and TK Bioanalytical Services
- Bioavailability Study Support
- PK Bioanalysis by ICP-MS
- Exploratory Pharmacokinetics
- GLP Bioanalysis
- PK Analysis – Clinical and Preclincal
- Large Molecule Bioanalysis
- Small Molecule Bioanalysis
- Intact Mass Analysis
- MSD (Meso Scale Discovery) Toxicity Screening
- Instrumentation Details
LC/MS Assay Development in CSF
Pacific BioLabs has worked on method development to measure a small molecule for the treatment of multiple neurodegenerative diseases such as Alzheimer’s and related taupathies. We developed a method to measure the drug in both plasma and cerebrospinal fluid (CSF). Our scientists in collaboration with the client, correlated the plasma and CSF levels with clinical outcomes. There were unique bioanalytical challenges associated with this method. Our scientists had to consider the blood brain barrier, CSF sampling and assay sensitivity.
Read More About Pharmacokinetics and Toxicokinetics Bioanalysis Testing
- PBL Case Study – In Vitro Drug-Drug Interaction Studies
- PBL’s Learning Center – Large Molecule Bioanalysis
- PBL’s Learning Center – Preclinical Tests Timeline
- PBL’s Learning Center – Stages of Drug Development
- PBL’s Learning Center – MSD used for PK and PD studies
- PBL’s Learning Center – MSD to Assess Toxic Affects
PBL’s Preclinical Toxicology Booklet
Download the free booklet