Bioanalytical Method Development: High-Quality Data for your IND or NDA Filing to US FDA
Analytical method development is a procedure for reliable detection of analytes of interest. High-grade method development ensures that the method is suitable for full validation and high-quality analysis of drugs, metabolites, and biomarkers in biological matrices.As the number of drugs released in the market is increasing by the day, so is the need for method development and validation. These new drugs may be compounds never used before or modification of existing drugs. Inability to relate analytical procedures, as well as reference and internal standards for new drugs, hinders their thorough R&D. Hence, it becomes necessary to develop new analytical methods for studying the effect of drug compounds. These methods are designed to understand the identity, characteristics, purity, and potency of drug compounds.
During drug research, the developed analytical methods are utilized to measure and define the required dosage, acceptable impurity, observed stability, and bioavailability of the drug. Overall, analytical method development ensures product consistency, allowing the release of reliable drug products in the market.
Bioanalytical Method Development and Validation: From Drug Discovery to Clinical Trials
Drug development is an intricate process involving several phases. Analytical method development starts closer to the beginning of the drug development process at the discovery stage itself. Method development for a New Chemical Entity (NCE) enables analysis in biological matrices for evaluation of drug pharmacology properties, such as bioavailability. Generally, a non-validated method is deployed at this stage of early drug discovery. As the drug progresses to IND enabling studies, however, further method development is required given the need for method robustness and full validation. Even more method development may be needed eventually, due to the change in matrices from animal species to human, as the drug moves farther into Phase I.
During drug discovery, scientists identify novel treatment targets, synthesize new molecules, screen these molecules in ‘in vivo’ and ‘in vitro’ assay, and study physicochemical aspects of the molecules. Multiple NCE are tested to determine the compound that may be best suited for the development of a drug, and each of these NCE requires prompt method development.
Several analytical methods are developed for testing the samples of different compounds in a variety of species. These methods eventually would be adapted to human samples. Adequate method development during the preclinical stage is essential for a straightforward transition from animal species to Clinical phase.
During clinical trials, method development helps mark a safe dose for human consumption. These trials are performed on human volunteers to ensure the stability, reliability, and effectiveness of the drug products and associated compounds. Usually, methods developed during the preclinical phase are modified and applied to human plasma samples at this stage. Further analytical method development is often required as more is discovered about the drug and its metabolism in this phase, necessitating the analysis for metabolites as well.