PK labs form a competent unit to help researchers and clinicians with pharmacokinetics services. Today pharmacokinetics labs incorporate pharmacology, pharmacokinetics, and pharmacometrics. From the above three services, pharmacometrics is concerned with the quantitative analysis of diseases, the effects of drugs, and their variability. Pharmacometrics is a merger of different fields of pharmacology, including pharmacokinetics and pharmacodynamics, disease biology, computer simulation, and biostatistics.
PK labs offer numerous services, including PK ADA assessments and MSD assay for pharmacokinetic and pharmacodynamic evaluations. The current article dives deep into PK labs to unearth different services and discoveries they provide in drug research and development.
Pharmacokinetics laboratories
Most PK labs operate on a model providing bioanalytical and pharmacokinetic services, PK sample analysis, and data modeling studies. PK labs expertly assess drugs and their metabolites in complex biological matrices such as blood, serum, plasma, saliva, urine, and CSF. Moreover, they have a comprehensive library of bioanalytical methods and standard operating procedures for all current technologies and method development and validation. Besides, all laboratory setup complies with good laboratory practices.
Pharmacokinetics laboratories offer state-of-the-art LC-MS, LC-MS/MS, and robust HPLC systems for PK sample analysis. Besides, enzymatic and ligand binding assays such as ELISA and MSD assay are complemented effectively with other laboratory equipment.
Bioanalytical studies are a critical aspect of pharmacokinetic laboratories. PK labs understand the importance and complexities of developing and testing PK samples. Therefore, they are always equipped to conduct both small-molecule and large-molecule pharmacokinetic studies.
Usually, PK labs employ ligand binding assays for large molecule bioanalysis. Over the years, MSD assays have emerged as a promising technique for large-molecule PK studies. Besides, PK labs may also opt for hybrid LC-MS systems for large molecule bioanalysis.
On the other hand, PK labs prefer LC-MS systems for small molecule PK studies. Over the last decade, the sensitivity of LC-MS/MS systems has increased from the picogram range to the nanogram range. Sensitivity is vital for small molecule PK studies. Therefore, PK labs employ highly sensitive LC-MS/MS systems for small molecule PK studies.
Additionally, PK labs have deep expertise in bioanalytical method development and validation. Developing bioanalytical methods early during the discovery phase is vital for accelerating drug development studies. Generally, early PK bioanalysis is needed to evaluate and select lead compounds. Pharmacokinetics laboratories can rapidly develop bioanalytical methods to assess early PK data. Moreover, as a drug candidate enters the clinical phase, GLP and validated bioanalytical methods are required for PK bioanalysis.
Robust bioanalytical validation is not only a regulatory requirement, but it ensures accurate and consistent results. Besides, a fully validated bioanalytical method is required in all clinical studies. PK labs have extensive experience in validating bioanalytical methods. They ensure the reliability of bioanalytical assays by testing for specificity, selectivity, linearity, accuracy, precision, matrix effects, stability, and reproducibility.
Conclusion
Pharmacokinetic services offer numerous bioanalytical solutions to drug development companies and other sponsors. They are making them crucial in accelerating drug development timelines and transitioning a candidate drug from initial discovery studies to preclinical and clinical trials.
