Top Reasons To Invest in Bioanalytical Assay Method Development and Validation

Bioanalytical assay method development and validation play a vital role in the drug discovery cycle and drug development processes. Today bioanalytical methods are essential to perform pharmacokinetics, pharmacodynamics, and bioavailability studies during drug development. Hence, developing and validating robust bioanalytical assays remains crucial for discovering drug products and bringing them into the market.

The primary goal of bioanalytical assay development is to optimize assay parameters for the validation process. Once a method is developed, validation ensures that the assay is suitable for analyzing biological samples. Hence, the successful conduct of preclinical and clinical studies depends on the development and validation of bioanalytical assays. Following are the top reasons for bioanalytical testing services and assay development services to invest in assay development and validation.

Need for bioanalytical assay development

As newer drug products enter the market, sponsors continually focus on ANDA, NDA, and IND enabling studies. For the successful approval of these regulated studies, sponsors must conduct pharmacokinetics, bioavailability, bioequivalence, and other clinical and nonclinical studies. The successful conduct of these studies depends on the development of robust bioanalytical assays. Generally, bioanalytical assays are developed to study analytes in biological matrices, including blood, plasma, serum, or urine.

Robust drug development needs bioanalytical assays that are thoroughly developed and characterized to deliver reliable and accurate results. Each assay is unique, and its performance will vary from one analyte to another. There are several reasons for developing a bioanalytical assay. Some crucial reasons are:

• Lack of a suitable assay for the analyte of interest
• Available assays are not reliable
• Or existing assays are expensive.

Regulatory guidance provides recommendations for developing chromatographic and ligand-binding assays, as these are the most commonly employed study types. The guidelines also provide recommendations for developing and validating assays that are for in-study use. However, this regulatory guidance can be modified, but sponsors should support them with adequate studies and documents.

Need for bioanalytical assay validation

Assay validation is crucial to demonstrate the reliability of a particular method in producing reproducible and accurate results. Besides, if an assay is used to generate regulatory data, it must validate the bioanalytical assay. Importantly, initial validation is just the primary step, and sponsors must continually validate the method as new values are obtained during analysis. Validation involves using specific investigations and documentation to demonstrate the characteristic performance of an assay for its intended applications. Primary validation parameters include sensitivity, specificity, critical standards, range, robustness, the upper and lower limit of quantification, linearity, accuracy, precision, stability, and recovery. Some primary reasons for bioanalytical assay validation are:

• To demonstrate the reliability of the generated results
• Bioanalytical assays constantly undergo modifications, and sponsors can show that the improvements generate reliable results
• Each analyte is unique. Hence, validation ensures that the assay performs its intended role for the analyte of interest
• The ultimate aim of the investigation may influence the appropriateness of the bioanalytical assay. At times sponsors may conduct a study at different experimental sites. Hence, assay validation at each study site can help demonstrate inter-laboratory reliability.