Why Use Assay Development in Drug Discovery and Development?

Earlier, new drugs were developed with random screening to find the active ingredient in natural products. But now, this process is more regulated and organized. Various innovative tools and techniques are utilized to find an effective and safe drug compound which would aid a certain illness or disease. Assay development is one of these techniques that helps in drug discovery and development.

Before moving forward, let’s understand what bioanalytical assays are.

Bioanalytical Assay

A bioanalytical assay is a statistical procedure which quantifies a certain biological process. The output of these assays depends upon the quality of the signal used for measurements such as through fluorescence, absorbance, and radioactivity.

The assay quality plays a crucial role in effectively determining the biological process. This quality is dependent on the reproducibility and robustness of the given signal. Many other factors impact the quality of assay such as automation instrumentation, reagents, reaction conditions, etc.

Therefore, maintaining the quality of the assay is necessary to predict the pharmacological properties of a given sample matrix.

Assay Development and Assay Validation

Bioanalytical assay development is carried out with the aim of screening drug compounds for understanding the pharmacological properties and interactions of the compound in the human body. Having this knowledge related to the particular pathway of drug and disease progress helps scientists in developing comprehensive treatments for healing the underlying condition or disease.

Assay development and its optimization are usually considered a cyclical process where multiple variables are assessed and several parameters are utilized to offer an enhanced reading window to the experiment. The optimization of the experiment is dependent on the technology and techniques that are being used to develop the method.

Assay validation offers a clear safety profile of the assay being used. It demonstrates and verifies that the underlying assay is suitable for the intended use. However, it should be noted that rigorous assay validation should be carried out to allow the assay to perform effectively and robustly throughout the years of preclinical trials and experiments.

During these experiments, various false negatives and false positives are obtained, which may be thought of as normal. However, these results are usually due to poor sensitivity and selectivity of the developed method. Another essential aspect of assay development is the reproducibility of the drug assay, which can prove the statistical performance of the assay under specific laboratory conditions. Thus, specificity, selectivity, and reproducibility validation parameters are extremely essential for analytical assays.

Assay validation is not only important for proving the efficiency of the process for its intended use but also to prove the quality of whole experimentation. As assay validation leads to GLP (Good Laboratory Practices) compliance, the resultant assay development is of the highest quality best suited for pharmaceutical assessments.

Assay development plays a crucial role in drug discovery and development as it helps in assessing the pharmacological properties of the drug compound. Without these properties or efficient bioanalytical assays, it is not possible to reach FDA approval and develop a therapeutic drug product. However, if you have a robust and repeatable assay to accompany you, you may face lesser obstacles and the quality of the experiment would be high.

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