Analytical development in pharmacology is the process of developing and validating analytical methods to measure the properties of pharmaceutical products. These methods are used to identify, separate, and quantify the chemical components of drug products, and to ensure that the products are safe, effective, and of high quality. Analytical development involves:
--Identifying testing methodologies --Ensuring adherence to regulatory requirements --Validating the methods' appropriateness for their intended objectives --Selecting and optimizing analytical methods --Creating a systematic approach to evaluating and selecting suitable methods --Developing analytical methods that are sensitive, specific, and robust --Developing analytical methods that can measure the target attribute within acceptable limits of accuracy and precision
Analytical procedures are developed to test specific characteristics of the substances against the predefined acceptance criteria for such characteristics. The goal is to create a strategy to guarantee the drug substance or composition's identification, purity, and potency. Analytical methods can be used to identify, separate, quantify, and learn more about the chemical components in drug products intended for commercial manufacturing. What is analyte develo