CVG 2022 Seminar-1:Bioanalytical Testing for Clinical Studies
January 19 @ 5:30 pm to 6:30 pm
Speaker: Dr. Henrianna Pang
Seminar will be conducted online via Zoom @ 5:30 pm EDT
Bioanalytical methods to be used in preclinical and clinical studies must be validated and bioanalytical parameters established as defined in regulatory guidelines. This presentation will describe parameters and validation requirements for quantitative methods based on liquid chromatography-mass spectrometry/mass spectrometry (LC-MS/MS). Examples will be used to demonstrate method development and validation does not always stop at quantifying targeted dosed compound in plasma, biological modification (intended because prodrug is the dosed compound) and degradation products (like glucuronides formation) also required consideration and at times quantification.
Henrianna Pang is a pharmaceutical and academic research scientist with in-depth knowledge of mass spectrometry and chromatography. She has over twenty years of bioanalysis experience in pharmaceutical industry (proprietary and contract research laboratories) ranging from discovery, GLP preclinical, and clinical studies. Specializes in method development, validation, high throughput sample analysis and preliminary metabolites identification. She has over ten years of experience in academic research in mass spectrometric applications for wide range of chemical entities. She holds a Ph.D. in medicinal chemistry from University of Utah and a B.Sc. in chemistry from San Diego State University.