Dr. Perry G. Wang has been a chemist at US FDA since 2008. Prior to joining the FDA, he worked in the pharmaceutical and medical-device industry. He received his Ph.D. from Oregon State University.
He specializes in LC-MS/MS method development and validation for drugs, cosmetics, foods, and dietary supplements. He teaches these courses in his own capacity as a scientist, but not as an employee of the FDA.
This 10-hour short course is designed to offer practical training for the practicing scientists in the pharmaceutical industry. Validation of bioanalytical methods is crucial for the successful conduct of nonclinical, biopharmaceutics, and clinical pharmacology studies. This short course will focus on the bioanalytical method validation using LC-MS/MS. It will take the participants step-by-step through the concepts and techniques to validate bioanalytical methods. It also emphasizes problem-solving skills with real examples and case studies encountered in the pharmaceutical industry.
The participants will learn essential concepts from the Guidance for Bioanalytical Method Validation issued by FDA. The emphasis is on practical issues associated with the bioanalytical method validation. After this course, the participants will be able to independently validate their own bioanalytical methods. How to apply the validated methods for routine assay and some typical case studies will be presented as well.
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