Advanced Technologies for Pharmaceutical Analysis and Surveillance

John Kauffman, Division of Pharmaceutical Analysis, FDA, St. Louis, USA

Laboratory science plays a key role in regulatory decision making at the FDA Center for Drug Evaluation and Research though three channels. (1) Analytical methods that are submitted in new drug applications may be evaluated to determine if they are suitable for their intended purposes. (2) Adverse events associated with public health emergencies are often examined in the laboratory to contribute to root cause analysis. (3) Research projects and programs are established to both inform specific questions in regulatory science and to evaluate applications of new methodologies that may be useful in regulatory science.   

This presentation will provide examples of research programs currently in progress at the FDA Division of Pharmaceutical Analysis and their expected impact on regulatory science. These will include research programs utilizing state-of-the-art spectrometric technologies for pharmaceutical analysis and surveillance as well as chemometric approaches to method development and data analysis.