Single dose pharmacokinetics (PK) is the study of how the body absorbs, distributes, metabolizes, and excretes a single dose of a drug. This type of PK study is often used to determine the appropriate dose for a medication and to understand how a drug will behave in the body after it is administered. PK studies can help researchers and healthcare providers understand how a drug will interact with the body and predict its potential side effects. Single dose PK studies are an important part of the drug development process and can help ensure that medications are safe and effective for use in humans.
In a single dose PK experiment, the bioavailability of small-molecule drugs can be calculated by comparing the drug exposure of oral administration and systemic administration through a single administration and then testing the blood drug concentration of the compound in the animal.
A single dose PK study typically involves administering a single dose of a drug to a group of healthy volunteers or patients, and then collecting blood and urine samples at regular intervals over a period of time. These samples are then analyzed to determine the concentration of the drug in the body at each time point. This information can be used to calculate various PK parameters, such as the maximum concentration of the drug in the blood (Cmax), the time it takes for the drug to reach its maximum concentration (Tmax), and the half-life of the drug (the amount of time it takes for the concentration of the drug in the body to decrease by half). PK studies can also be used to evaluate the effects of different factors on the absorption, distribution, metabolism, and excretion of a drug, such as a person’s age, gender, weight, and genetic makeup.
There are several methods that can be used to analyze the data from a single dose PK study. One common method is known as non-compartmental analysis (NCA), which involves calculating PK parameters directly from the concentration-time data without making assumptions about the underlying pharmacokinetic model. NCA can be used to calculate a variety of PK parameters, such as the area under the concentration-time curve (AUC), the maximum concentration of the drug in the blood (Cmax), and the time it takes for the drug to reach its maximum concentration (Tmax).
Another method for analyzing single dose PK data is compartmental modeling, which involves fitting the concentration-time data to a mathematical model that describes the absorption, distribution, metabolism, and excretion of the drug in the body. This method can provide more detailed information about the PK of the drug and can be used to evaluate the effects of different factors on its behavior in the body.
Overall, the specific method used to analyze single dose PK data will depend on the goals of the study and the information that is needed. Both NCA and compartmental modeling can be useful for understanding the PK of a drug and for making decisions about its appropriate use in clinical settings.
PK driven SAR has become the new trends for lead optimizations. More and more companies are including a PK team within their medicinal chemistry division. However, the time and cost for initiating and maintaining such a program can be very costly that may not feasible at all for a small company. At AxisPharm, we can function just like your own pre-clinic PK team at a small fraction of cost compare with building such as team in house. Our expertise, experiences, and instrumentation are all within your reach.
AxisPharm is a San Diego based bioanalytical LC/MS/MS service provider with more than 25 years experience in the field. Our bioanalytical chemistry department specializes in developing and validating robust bioanalytical methods for PK/TK sample analysis of small molecules, proteins, peptides, and metabolites using LCMS/MS (HPLC, UPLC, on-line SPE), HPLC/UV, and HPLC/FL. We have experience analyzing API and metabolites in various biological matrices and can provide bioanalytical support throughout all the stages of drug development.