Guide To Understand How Bioanalysis Helps in Drug Development


Drug discovery and development is a highly advanced field in the modern world. Can you imagine the cost involved in drug discovery and development? It is approximately $1billion that goes behind the discovery of a new drug. And the minimum time for innovation and development of a single medicine in ten years. A vast array of processes goes behind individual drug development. Bioanalysis plays a significant role in this process. It is a term you frequently hear in the world of science today. It is a technique that assists numerous research works involving new chemical synthesis, pharmacological product synthesis, or any other job related to synthesis and analysis of biological molecules.

Bioanalysis for drug discovery or drug design

Drug design, which is the initial stage of drug discovery and development, also requires bioanalysis of the novel chemical compounds to claim them as potential drugs. At this stage, bioanalytical techniques are used to determine the suitable concentration of the chemical compound, which proves to be active on target body issues. Moreover, these techniques act as a screening tool. This means that in a situation where you have multiple new compounds, bioanalysis will screen out the non-effective, less-effective as well as toxic compounds and leave you with the novel chemical compounds that have the potential to act as drugs.

After this process, the compounds need to be tested for their solubility, stability as well as lipophilicity. These measures give a clear idea about the target of the drug and its action on the metabolism of the body. Bioanalytical techniques help in determining all these measures accurately and take you a step ahead of your drug discovery.

Bioanalysis for drug development

After the screening of chemical compounds, there are many steps to be covered before placing the drug in the market, which is collectively termed as drug development phases. Under this, the researchers or drug developers perform pre-clinical as well as clinical trials. They check the levels of effectiveness of the drug on the body of selected volunteers for the experiments. This again requires techniques like mass spectrometry. There are two primary components of bioanalytical methods involved in drug development:

1. Preparation of sample: 

Taking the biological samples like blood, saliva, plasma, serum, urine, etc. and analyzing them for determining the drug concentrations is a part of the sample preparation process for bioanalysis of drug action or pharmacokinetics. It is a crucial step in the drug discovery and development process before using it on animals or humans. Most of the assays are conducted to remove protein from the biological samples. This step involves protein precipitation, solid-phase extension, liquid-liquid extraction, etc. processes regularly.

2. Detection of the compound:

Different types of mass spectrometry and sometimes its combination with High-Performance Liquid Chromatography, i.e., HPLC-MS, are the methods used for the discovery of a chemical compound (drug).

But before performing all the bioanalytical processes, it is necessary to validate them, demonstrating that the method chosen by the researcher is the best suitable for getting/ analyzing the target drug compound. For the developmental studies, it is very crucial to focus on the Good Laboratory Practice (GLP) validated processes for bioanalysis.

Thus, bioanalysis and drug discovery and development go hand in hand and complement each other to bring a new efficient drug in the market.

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