Development and Validation of New Analytical Methods for Assay of Bioactive Molecules in Various Samples: A Comparative Perspective on Different Regulatory Authorities

The methodical process of determining if an analytical method is appropriate for its intended use is known as analytical method validation. For regulatory submissions or internal use, the technique's developer or user typically produces proof of the method's specificity, linearity, accuracy, precision, detection limit, quantitation limit, ruggedness, and robustness. The quality of the data shown here is directly impacted by the iterative process of technique development and validation. When creating quality and safety compliance data throughout drug product development and post-approval, validated analytical methodologies for qualitative or quantitative testing of drug molecules are crucial. Key elements of the cycle of developing and validating analytical techniques are attempted to be explained in the current study. Additionally, it aims to analyze and compile standards published by different organizations for analytical techniques used to examine pharmaceutical formulations and pharmacological substances in their pure form.