Journal of Analytical & Bioanalytical Techniques
Open Access

Abstract

Qualitative and quantitative methods using LC-MS/MS have been becoming increasingly important and useful to support drug research and development. Automation with high throughputplays a signifi cant role in discovery and development programs withobvious tributes and prospects. Method selectivity, sensitivity and reliability are necessary to ensure the quality and integrity of data required for regulatory submissions and approvals. Applications of LC-MS/MSwithcase studies (in- vitro ADME, in-vivo PK/TK and preclinical and clinical bioanalysis) will be presented and discussed. It is apparent that Bioanalysis is a central and vital function for drug discovery & development processes. Fast turnaround and reliability of data facilitate optimization and enhance successful evaluation and selection process. Accelerated and accurate evaluationsmake right decisions for nomination and development programs. Automation and robustness of bioanalysis ensure high quality and integrity of data for successful submissions (IND/NDA).

Biography

Dr. Michael Zhou is currently Senior Director of Global R&D at BioAnalytical Systems, Inc., with most recent roles as Senior Associate at Lachman Consultants and Director of Bioanalytical Chemistry/DMPK at Synta Pharmaceuticals Corporation. He previously held positions at DuPont, Purdue Pharma LP, Johnson & Johnson, Cardinal Health, and Scynexis with increasing responsibilities for analytical, bioanalytical and DMPK R&D in support of drug/product discovery and development. His career has focused on analytical and bioanalytical R&D plus DMPK programs for over 20 years, with expertise in regulatory compliance such as GLP, GCP, GCLP, cGMP regulations (or GxPs), and ICH, AMV and BMV guidelines. During his career tenure, he has gone through a few FDA audits with great success. He has been actively involved in organizing conferences, speaking at presentations and sharing his knowledge at workshops / short courses for numerous national and international proceedings. He serves as a member of scienti fi c steering committees for PBA and NABF, and is a member of AAPS, ACS, ASMS and AACR. He authored over 40 research articles and 2 book chapters in the areas of analytical/bioanalytical chemistry. He is a peer-reviewer for several renowned technical journals including J. AOAC International, J. Analytical Chemistry, J. PBA, and J. Chromatogr. B, etc. He serves as an Editorial Board Member for ?Bioanalysis,? edited by Future Science Group of London, UK. He was retained by John Wiley and Sons (a world renowned scienti fi c publisher) for a book entitled ?Regulated Bioanalytical Laboratories: Technical and Regulatory Aspects from Global Perspectives? (published in January 2011). He received his Ph.D. from the University of Delaware under the supervision of Dr. Donald L. Sparks, Chair and DuPont Professor.