TK/PK Testing
What is Pharmacokinetics (PK)?
Advanced Platforms Supporting PK
Our Experience on PK Assays
Regulatory Guidance
What is Pharmacokinetics (PK)?
Pharmacokinetics (PK) describes the time-dependent absorption, distribution, metabolism, and excretion of a given pharmaceuticals to the body. PK analysis is performed in different biological fluids, including serum, plasma, urine, and saliva, throughout the drug development process, starting from early discovery to the last Phase studies. A comprehensive PK analysis enables a proper understanding in a drug’s interaction with the body, as well as the intensity and duration of its efficacy.
Bioanalytical methods that determine time-concentration profiles of the drug providing essential information for PK analysis. Preclinical PK analysis usually evaluates the bioavailability, distribution, half-life, and clearance of testing drug candidates. Together with results of PK studies in multiple species, clinical PK can be predicted with estimated dose for clinical efficacy with maximum effectiveness while reducing adverse effects. Drugs can be advanced farther into clinical development based on the preclinical results.
Advanced Platforms Supporting PK
More analytical technologies with high accuracy and sensitivity can be used in large molecules, biological therapeutics and ligand binding assay. Triangle Laboratory will provide solution to help you find the best analytical platform not only for your project in early or late stage of drug discovery but also in the preclinical and clinical phase. The platforms listed below have been successfully proven to evaluate pharmacokinetic and pharmacodynamic behavior of candidates drug.
MESO SECTOR
Bio-Plex Liquid Array Multiplexing System
xMark™ Microplate Absorbance Spectrophotometer
Gyrolab
Our Experience on PK Assays
We have a team of scientists with extensive experience in developing and validating pharmacokinetic assays and delivering robust assays with remarkable results with high precision and accuracy, selectivity, and specificity, etc., following the FDA guidance.
With our built-in antibody conjugation capabilities to generate labeled high affinity and specificity anti-idiotypic antibodies, we can deliver high sensitivity PK assays with excellent selectivity and robustness.
Our AI assisted assay development system is also able to guide our research for personalized and customized purposes. The machine learning enabled buffer selection software can also select the buffers based on the assay types, drug modality, assay platform, and matrixes.
Regulatory Guidance
Bioanalytical Method Validation
