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Critical role of PK studies during Drug Discovery and Development

The pharmacokinetics studies or PK assay are conducted in bioanalytical laboratories to determine the concentration level of a drug compound in the human body. These studies quantify the processes of Absorption, Distribution, Metabolism, and Excretion or ADME. A complex array of mass spectrometry method set-up and sample analysis is utilized to quantitate drug levels from PK clinical trials for varying doses over an extended time period.

It is essential to know how ADME works for understanding the role of PK studies conducted at bioanalysis labs.


The process of a drug journey in the body begins with absorption. In drug discovery and development, this study evaluates the rate and extent to which the drug gets absorbed. Since the GI tract is considered one the most common sites of drug absorption, these studies focus on understanding the psychochemical parameters and the concentration of drug compound at the site of action. The level of absorption in a preclinical trial predicts the absorption rate in the human body.


Once the drug compound is absorbed, it is then sent out or distributed from the site of absorption to the site of action. An in-depth PK analysis is essential to establish how is the drug transported, what are the chemical and biological interactions with analytes and proteins, and what are the level of concentration at the site of action.


Once a specified concentration of the drug compound reaches the site of action, PK studies are required to study how a drug compound transforms irreversibly into metabolites. Rate of metabolism is used to study the route of administration and metabolic activity.


Once the drug is absorbed, distributed, and metabolized, the compound along with other toxic elements are excreted. In a PK clinical trial, understanding the excretion process is essential, because if the drug compound is not excreted properly, it can lead to chemical buildup and increased toxicity that cause potential harm.


One of the major aims of the PK clinical trials is to establish the efficacy of the drug compound and allow manufacturers to take the drug to the market. The earlier studies are conducted on animals, usually rats. Enough data, including values and variances, is shared with the FDA to get approvals and demonstrate drug safety for clinical trials. During clinical trials, the data is collected and collated as per the FDA guidelines to create recognizable drug design ready for market.


Results obtained from PK studies help other laboratories design and conduct clinical trials for drug development in the future. They help determine the correct dose for a drug candidate and are particularly useful with bioequivalence studies. Some that are covered include genotype of the drug-metabolism enzymes as well as prediction related to drug interaction and therapeutic drug monitoring.

In summary, PK analysis or ADME studies offer ethical and tactical assays to establish the veracity of a compound and its effectiveness against diseases, taking into consideration environmental and genetic factors

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