Biomarkers have been contributing widely in the process of drug discovery and development. Since they have become an integrated part of the drug development and clinical trial process, assuring their quality and establishing their assay validation is of crucial importance. New biomarkers have proven their potency in revolutionizing the development and applicability of the therapeutics; however, has been considered to be contingent with the establishment of a concrete process of biomarker validation. For a successful drug discovery and development process, it is important that the biomarker validation sufficiently addresses the requirement of technology integration and method validation.
Successful biomarker assay development and biomarker validation requires a thorough understanding of exactly which analytical method is sufficient enough and how well is it performing. Once, the researcher possesses sufficient knowledge in this context, experiments can then be subsequently designed for testing the developed method and proving the assay performance. Researchers have timely considered the necessity for validating the bioanalytical method for biomarker detection and quantification and the criteria set for the same involves the following –
What type of the question would your discovered biomarker answer?
What is the degree of certainty requiring your desired answer to address your first question?
What should be the assumptions to state the relationship between the biomarker change and the clinical endpoints?
Usually, biomarker validation should be potent enough for demonstrating that the method developed is reliable to address its intended purpose. Accordingly, the biomarker assay validation’s rigour increases with the increase in advanced clinical trials or the associated decision-making process. For all the biomarker assays, adopting a continuous and evolving strategy for fit-for-purpose biomarker detection is important. This fit-for-purpose biomarker validation provides sufficient information regarding drug discovery and development by conserving several resources that might be efficient throughout the exploratory stages of the characterization of the biomarkers.
A successful biomarker strategy facilitates the process of drug discovery and development in several different ways. The biomarkers can provide aid in demonstrating the engagement of the drug targets to assist in the determination of appropriate drug dosage, providing early assessment of the safety and efficacy profiling of the drug candidates under analysis. Biomarkers can also aid in the optimization process of drug efficacy by selecting the appropriate patients.
For every stage bioanalytical strategy, the fit-for-purpose or FFP can and should be implemented ensuring that the biomarker assay has been characterised to that extent up to which it has been detected suitable for its intended therapeutic application. Biomarker data impacting the safety and efficacy profiling of the pharmaceutical drug candidate either in non-clinical or clinical studies should be easily derived across all fully validated assays. Such assays have been selected for supporting pivotal Phase III studies whose results may include drug product labelling shall also be further validated. In case of exploratory biomarkers, qualification requires significantly lesser quantities of reagents and subsequent assay runs thereby assessing fewer assay parameters compared to its validation. The critical parameters for successfully establishing biomarker qualification and validation should mandatorily include detection of robustness, stability, and ruggedness of the pharmaceutical drug candidate under analysis.
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