Importance Of Assay Validation In The Development Of New Drugs

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Drug development has undoubtedly taken a positive turn within the last 10 years, although the situation was not as good before this time. Most drugs failed after Phase I clinical trials and was a challenge the rest found difficult to pass through. 

This challenging situation leads to multiple types of research, which finally led to the discovery of a measure that could rule out the possibility of a drug failing during Phase I; this little discovery was named a biomarker. Here’s more on how biomarkers changed the course of drug development. 

What are biomarkers?

Biomarkers are essentially molecules acting as pharmacological tools that indicate normal bodily functions and help in detection, diagnosis, and methods of treatment for a disease. This essential tool has been utilized to test whether or not a certain drug metabolite has the efficacy to pass through the research stages and reach a developmental phase. 

Importance of Assay Validation

Although there are multiple complex reasoning behind why an assay validation is necessary, the simplest of them all is that it provides a conclusive opinion of whether or not a drug component is capable of serving the desired purpose. Even in 2006, only about 8% of the tested products were able to reach the Phase I trials. This gave rise to the need for a better tool and technique in new drug development. 

Even after significant advances in medicine and drug discovery, which finally reached a measurable new drug target level, the development of novel therapies was yet at a standstill even 10 years back. Very few drugs were able to make it out of clinical trials, and the numbers of those that were launched in the market for use were even lower. 

Assay development and validation is an important technique to determine whether or not a biomarker is capable of reproducing accurate data. This is a crucial step in ensuring that the entire drug development process takes into account high-quality and well-researched data before the trials begin. 

Biomarker assay validation or bioanalytical assays are designed before the clinical trials start. For new drug development, this is when assay development and validation is required to ensure the simultaneous search for useful biomarkers in the pharmacodynamics process. 

For example, in the field of oncology, significant progress has been achieved as these were used instead of clinical endpoints. Assay development and validation bear the significance it has due to the simultaneous study that goes on before the drug trials are even commenced. This ensures that a ton of money and time isn’t wasted on metabolites or compounds that aren’t capable of passing the benchmark and making it to Phase I. 

Assay validation has proven to be a crucial step which has provided the capability for potential metabolites to enter the testing phase quicker. Besides this, labs use this method to ensure that their tests come out with accurate data for further improvement of drug and development of a new drug. This technique has more scope for research and development in the future.