In Vitro Assay Development for Pharmacokinetic Studies

Developing a new drug product takes around 10 to 15 years. Besides, it’s an extremely complex and costly process needing multiple bioanalytical assays and tests. Efficacy and safety are some of the most crucial considerations while developing a drug product. These parameters are vital, from early lead generation studies to later stages of clinical development. Hence, drug developers often rely on in vitro assay development solutions for generating high-quality safety and efficacy data. The current article focuses on in vitro assay development services for pharmacokinetic testing. 

In vitro analytical assay development

In vitro assay development for pharmacokinetic studies can be divided into two individual components: in vitro assays and pharmacokinetic studies. So, In vitro testing refers to experiments conducted outside biological environments, while pharmacokinetic studies evaluate absorption, distribution, metabolism, and excretion characteristics. Hence, the primary objective of in vitro development and assay qualification for pharmacokinetic studies is to assess the biological activity of a drug product outside a living organism. 

During the early stages of drug discovery, researchers focus on understanding the structural motifs and physiological properties that alter safety and efficacy profiles. ADME studies are vital for understanding drug metabolism and potential drug interactions. Here, in vitro ADME studies help identify the early attributes of absorption, distribution, metabolism, and excretion profile. Early drug screening assays include several services, such as in vitro ADME assessments, expert studies, and data interpretation solutions. 

Ideally, assessing a drug’s ADME properties and its potential interactions should be completed as early as possible. This approach helps identify potential drug molecules that have the desired efficacy through more targeted analysis. Besides, multiple assay formats suitable for individual stages of drug discovery and development provide a flexible system for pharmacokinetic testing. 

Moreover, in vitro pharmacokinetic assessments during drug discovery are critical for identifying, discovering, and optimizing lead compounds. During the preliminary target identification stage, in vitro assay can help researchers understand diseases and medical conditions, making it possible to identify new therapeutic targets. 

Identifying drug targets is then followed by screening drug libraries to identify candidates with desired properties. A pool of additional experimental tests helps researchers narrow down to the most promising lead compounds. Although newer in silico screening methods are helping researchers save time and resources, in vitro assays are still crucial for validating experimental predictions. Finally, the last type of early drug discovery is lead optimization. This stage ensures that the lead compounds are significantly optimized to achieve the desired biological activity. After each round of designing, synthesizing, and characterizing the lead compounds, drug developers accumulate data to draw a better picture of their structure and activity. Here, in vitro pharmacokinetic testing is critical for generating high-quality safety and efficacy data. This testing is continued during the preclinical trial. 

On average, one out of 5000 potential drug compounds entering preclinical trials reaches the commercialization stage. The primary reason for this comprehensive decline is that during the early preclinical stage, drug developers don’t have enough data regarding safety, efficacy, pharmacokinetics, metabolism, and toxicity properties. Hence, during the preclinical stage, compounds are revaluated through in vitro and in vivo testing. These early assessments are crucial for identifying safety and efficacy profiles and also first in human doses for subsequent human studies.