An Introduction To Pk Drug Analysis Concepts In Clinical Research

By Author: Maria Brown
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Pharmacokinetics is defined as the study of the effects that a drug produces on the living model under clinical trials. Most of the pharmaceutical analysis involves the measurement of a particular pharmaceutical compound being analysed in a physiological fluid. Examples of such physiological fluids used in bioanalysis are plasma, blood, saliva (occasionally), and serum.

The pharmacokinetic study involved in early clinical research can be divided into two different types – compartmental and non-compartmental. The non-compartmental analysis consists of a series of calculations estimating the exposures and elimination characteristics of the pharmaceutical compounds under analysis. The parameters such as AUC (area under the curve) and maximum exposure (Cmax) are calculated and further interpreted where you have no other pk drug information in hand. Such Pk parameters are used for indicating the concentration of drug content into the human body. Also, it proves to help estimate the peak drug concentration that is achieved.

Pharmacokinetic ...
... definition -

The pharmacokinetic assay is defined as the process of studying the course of drug absorption, distribution, metabolism, and excretion. The primary goal of this study involves enhancing the drug efficacy, thereby decreasing toxicity of therapeutic treatment of the subjects undergoing clinical studies. The existence of the strong correlations between the concentration of the pharmaceutical drug and the pharmacological responses generated by these drugs.

Purpose of the pharmacokinetic study –

The topmost emphasis of any drug disposition studies is obtaining relationship and the correlation between the absorption, distribution, metabolism, and excretion characteristics of the pharmaceutical drug candidate under evaluation. These types of drug studies are accomplished both under clinical and non-clinical environments. The blood level determinations performed under phase 1, phase 2, and phase 3 studies are included under most of the clinical study protocols.

Models used in pharmacokinetic assays –

The process of handling a pharmaceutical drug within a human body may be complicated as it represents an amalgamation of several processes working in conjunction to alter the concentration of pharmaceutical drugs both in tissues and fluids. To predict how a drug behaves within the human body, it is essential to simplify the complex body processes. One easy way of simplifying these complex body processes is by applying mathematical principles. A basic and perhaps the most preferred model employed in the pharmacokinetic drug estimation is the compartmental model – one compartment, two-compartmental models, and multi-compartment models.

Applications of the PK/PD analysis –

The applications of the pk sample analysis are summarised as follows –

Predicting the drug dosage requirements –
PK/PD model system assists in predicting the dosage requirements much early in the process of drug discovery and development. This makes the first-dose range-finding study to be both informative and consequential.

Characterising the extent of drug exposure –

By delivering drug intravenously, only a fraction of it gets absorbed within the human body and becomes pharmacologically active. Quantification of both the rate and magnitude of the drug exposure has proved to be critical for determining its biomarker analysis services use.

Assessing changes for the dosing schedule –

Predicting the biological consequences of even the small drug dosing schedule is imperative for the drug discovery and development process. This is important as both the alterations and formulation changes are critical and witnessed throughout the drug discovery and development process.