Pharmacokinetics studies drug interaction with the body from the time it is administered to its excretion from the body. In drug development, pharmacokinetic studies involve in vitro assay development in preclinical testing and PK analysis in clinical trials, including testing in human subjects. Pharmacokinetic studies focus on drug movement based on the absorption, distribution, metabolism, and excretion profiles.
Pharmacokinetic studies are a crucial aspect of drug development and their data are necessary while submission of documentation to regulatory agencies. However, designing, developing, and conducting pharmacokinetic analysis can be complex and challenging. It requires a multi-disciplinary team, including bioanalytical scientists, chemists, biostatisticians, and pharmacokinetic scientists, along with access to robust bioanalytical facilities and state-of-the-art technology. Pharmacokinetic CRO fulfills all these criteria. Whether it’s PK ADA analysis, cytokine assay services, or evaluating PK samples in clinical trials, PK CRO is at the forefront of delivering robust pharmacokinetic data. The current article discusses the role of pharmacokinetic CRO in drug development.
Pharmacokinetic studies in drug discovery and development
Pharmacokinetic studies investigate the absorption, distribution analysis, including protein binding information, metabolism, and excretion, including variation observed among individuals. Preclinical pharmacokinetic testing includes animal models such as rats, dogs, etc., whereas clinical testing includes healthy volunteers and the patient population. Researchers evaluate pharmacokinetic parameters by assessing blood or urine samples obtained at different intervals after administering the drug of interest. However, all samples should be collected and handled following standardized procedures to ensure accuracy and minimize variability.
Scientists calculate different pharmacokinetic parameters such as C-max, t-max, the area under the curve, drug half-life and clearance, and volume of distribution. Besides, pharmacokinetic CROs carefully plan the sampling frequency to ensure they have enough time points for assessments. Pharmacokinetic CRO also identifies the optimum dosage and frequency for administering new drug entities in study subjects. Through single-dose and multiple-dose assessments, researchers identify accurate doses for a particular duration that enables the establishment of steady-state concentrations and their associated variability and dose dependency through PK clinical trials.
Pharmacokinetics and pharmacodynamics modeling demonstrate the relationship between drug response and exposure. Identifying this relationship helps researchers decide and conduct relevant drug interaction studies. Additionally, if researchers identify issues related to drug absorption due to interaction with food, they also perform food effect research to evaluate these interactions and their effect on drug efficacy and safety.
Most importantly, pharmacokinetic CRO designs robust clinical trials based on data sets from preclinical PK analysis. Preclinical pharmacokinetic analysis helps increase the likelihood of achieving ideal therapeutic exposure during the early stages of clinical trials using specific dosing regimens. Besides, they apply best practices and follow regulatory recommendations to generate experimental PK data using advanced methodology and a thorough understanding of drug properties before initiating clinical drug development. This approach maximizes the chances of a drug candidate reaching later stages of clinical trial and eventually post-marketing evaluation.
In Conclusion
Pharmacokinetic CROs are critical to understanding ADME properties and using them for developing safe and effective drug products.
