In the process of drug testing for consequent drug development, drug metabolism, and pharmacokinetics (PK) is a critical component.
PK is the study of a drug’s absorption, distribution, and metabolism.
Bioanalysis is a PK function and a drug metabolism process. It is a kind of quantitative measurement of the drug.
The measurement is done in biological matrices, like urine, tissue samples, and plasma to determine PK and pharmacodynamics.
Discovering and developing a new drug is a time-consuming and expensive affair. This development process generates compounds and studies their properties in details. This ascertains if it is feasible to select a Novel Chemical Entity (NCE) to become a drug that will be effective and safe.
The bioanalytical data that clinical scientists generate during the discovery and the pre-clinical stages act as a guide for the early-stage clinical programs. From these programs, scientists obtain plasma concentration-response data that they compare with those obtained in vivo (from dosed animals in a bioanalytical laboratory).
Indispensable Role in Drug Development and Testing
Determining the drug concentration in biological fluids, like the serum, plasma, or urine helps to provide data that scientists use in understanding the time course of drug action, or PK, in vivo (animal/human) and is a critical part of the discovery and development process of a drug.
In a bioanalysis lab during the drug testing and the discovery process, clinical scientists identify and characterize new enzymes or receptors. They also conduct synthesis and screening procedures for the in vivo biological activities.
Scientists use the pharmacokinetic parameters to understand and evaluate the drug molecule’s absorption, distribution, metabolism, and excretion (ADME) process. For this, they obtain in vivo samples. It is important to administer the drug to specifically selected animal species (both intravenous and oral) to understand bioavailability and in vivo characterization of PK.
After a certain time, they collect whole blood samples from the species. Then, the scientists use an appropriate bioanalytical process to quantify the drug in the already harvested plasma.
In this connection, let’s take a look at the main PK process that is the ADME process.
This is the process by which drugs gain entry into the body. They should enter in any non-intravenous way (dermal, oral, nasal, etc.). Several factors affect the absorption, like the drug’s psychochemical parameters, drug concentration, etc.
The drugs move all over the body in the process of distribution. Once in the blood, the drugs need to enter the cells after entering the tissues and reaching the cell membranes.
Metabolism is the process by which the drug undergoes a chemical alteration. This increases their water solubility factor so that they can be excreted more easily.
This is the process of the drugs and other toxic substances leaving the body.
Thus, for the drug to proceed from the pre-clinical stage to the clinical one, bioanalysis of the in vivo PK samples is extremely critical.
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