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Beginner’s Guide to The Right Bioanalytical Testing For A Drug Development Program

The primary goal of drug discovery and development is to identify and evaluate novel chemical entities for developing safe and efficacious drug products An entire drug discovery and development process of a new drug product costs around $1 billion and takes approx 10-12 years to reach the market.. Hence, bioanalytical methods necessary for drug testing are critical for the success of drug development projects.

The need for robust bioanalytical testing is well understood and accepted globally. Over the years, several bioanalytical assays have been developed to support compounds at different drug discovery and development steps. Moreover, numerous bioanalytical methods are now available for novel and generic drug products. However, adequate bioanalytical assay development and validation are necessary for using them in routine analysis. Sponsors employ different strategies and methods in drug discovery and development processes. This article is a beginner’s guide on how to select the right bioanalytical testing for a drug development program. For simplicity, we discuss bioanalytical testing in drug discovery vs. drug development.

Bioanalytical testing in drug discovery

The initial aim of bioanalytical testing in the drug discovery process is to provide reasonable bioanalysis to form an informed decision for identifying potential drug compounds. Hence, simple yet rapid bioanalytical assays are developed in the initial stages of drug discovery. Sometimes these initial methods, with some modifications, may be used as the method of choice in the preclinical development stage.

Drug discovery involves identifying and characterizing potential drug compounds, lead molecules synthesis, screening lead molecules through in vivo and in vitro approaches, and physicochemical classification of lead molecules. Sponsors employ automated techniques to carry out throughput screening of tens of thousands of potential compounds in a single day. This screening is followed by a secondary stage, where selected compounds are analyzed for physicochemical properties and stability characteristics. Besides, sponsors apply bioanalytical testing to conduct parallel studies for evaluating ADME properties of drug products.

Bioanalytical testing in drug development

The drug development process focuses on assessing the safety, toxicity, and efficacy of a novel drug compound. However, extensive preclinical studies are performed before testing a new drug in human subjects. These studies primarily determine the safety profile of a drug product. Each drug product may undergo distinct preclinical research, such as PK/PD analysis, ADME properties, and toxicity testing.

Clinical trials form the core of a drug development process. They are necessary to assess drug safety and efficacy in humans. Clinical trials consist of four primary phases; Phase I, II, III, and IV. Each clinical trial phase is crucial for decision-making. Hence, a drug may get terminated at any stage for any valid reason. As clinical trials assess drug molecules in humans, bioanalytical testing needs to be more robust and reliable to withstand rigorous testing in different phases of drug development.

The road ahead for bioanalytical testing

As discussed above, it is evident that bioanalytical methods are vital for the success of a novel drug entity throughout the discovery and development phases. Hence, sponsors should focus on adequate bioanalytical development and validation to demonstrate its reliability in drug testing.

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