What Do You Need To Know About Bioanalysis In Small Molecule Drug Development?

Small molecules and bioanalysis go hand in hand as they are both equally essential in the field of drug development. For a quantitative and qualitative study of small molecules, it is necessary to develop processes and study methods that generate desired results. Simply said, bioanalysis is used to discover small molecules that would help develop drug components for pre-selected purposes. Bioanalysis goes a long way to discover the most efficient of small molecules to target disease in the human body and is an integral part of good lab practices.

What Role Does Bioanalysis Play In Small Molecule Discovery?

Bioanalysis has a major role to play in lead development for drugs. The process for the entire development starts to test probable drug compounds in vitro, where the model expects the drug component to target disease specifically. If any such compound is found to be active in vitro, it moves on to another test in vivo.

Right after this, the bioanalytical part comes in. With the help of a biological matrix, bioanalytics studies are carried out followed by pharmacokinetics studies to check specific parameters like Cmax, Tmax, et cetera. If the lead (the small molecule discovered) is then found to be suitable for development, it passes on to the lead optimization phase. So, the bioanalytics study acts as the epicenter for drug development.

What Does A Bioanalytics Study Comprise Of?

The aspect of this study has a broad spectrum, but it generally comprises detecting quantitative measurements of the small molecules in body fluids. This measurement is carried out in mediums like plasma, serum, blood, and even in small extracts of tissue. This process mainly consists of two parts, sample preparation, and compound detection.

Sample Preparation In A Bioanalytical Lab

Some pharmaceuticals carry out such studies in non-GLP (Good Laboratory Practices), avoiding FDA protocols. This is to be avoided at all costs because bioanalysis results matter a lot for further development, and anything going wrong means starting from scratch again. In a GLP bioanalytical lab, sample preparation involves cleaning a sample or concentrating it for a better and more accurate result.

This will help understand the course of time taken by a drug to work in a human body. So sample preparation is of extreme importance here. The process used in sample preparation involves eliminating protein from the sample, extraction of solid phase, and liquid-liquid extraction.

Compound Detection In Bioanalysis

The best-practiced technique here is to use high performance liquid chromatography (HPL) paired with mass spectrometry. An efficient lab would choose a triple quadrupole mass spectrometer, which provides an optional selected reaction monitoring mode. This would offer results that are highly specific, sensitive within a dynamic range.

Before this entire process even starts, there is always a need to show and prove that the bioanalytical methods used are relevant for certain drug development. There are tons of FDA parameters that judge whether or not a GLP is using a valid bioanalytical method. These parameters act as guidelines for good lab practices and validate a bioanalysis method.