A Roadmap of Drug Development and Analytical Method Progression
Drug Development is a complex and lengthy process that requires extensive testing and characterization of the molecule to ensure safety, efficacy, and potency of the molecule. One crucial aspect of this process is analytical method development and validation. Analytical method development is the process of selecting and optimizing analytical methods to measure a specific attribute of a drug substance or drug product. This process entails a systematic approach to evaluating and selecting appropriate methods that are sensitive, specific, and robust, and capable of measuring the attributes of the drug molecule within acceptable limits of accuracy and precision. There are several guidelines globally that govern how analytical methods should be validated; however, the International Council for Harmonization (ICH) is a widely accepted guidance. In drug development, the progression of analytical methods typically starts with basic characterization techniques during early discovery phases, gradually evolving to highly sensitive and specific methods for preclinical studies and finally reaching robust and validated methods suitable for large-scale clinical trials and post-market monitoring, ensuring the quality and safety of the drug throughout its lifecycle. Throughout the development process, regulatory agencies like the FDA monitor and review data to ensure the safety and efficacy of the drug. ICH and the United States Pharmacopoeia Forum (USP-PF) recommend the Quality by Design (QbD) approach for the analytical method development and life cycle management. The QbD approach reduces the time and effort necessary to develop reliable analytical methods and lowers the out-of-specification (OOS) results during product testing. This paper describes the steps involved in new drug development and delves into how analytical method lifecycle proceeds throughout the clinical development of a drug molecule.