Regulated Bioanalysis: Fundamentals and Practice

Mario Rocci earned a Ph.D. in Pharmaceutics and a B.S. in Pharmacy from the State University of New York at Buffalo. He then joined Prevalere and developed the Pharmaceutical and Chemical Analysis business sector. Mario is well known throughout the pharmaceutical industry and has served as the President of the American Association of Pharmaceutical Scientists (AAPS), a professional society of over 13,000 members. He also serves on the Board of Pharmaceutical Sciences for the International Pharmaceutical Federation (FIP) and is Chairman of the Board of the Product Quality Research Institute (PQRI). Dr. Rocci has authored over 125 scientific publications and has extensive experience in the pharmaceutical sciences and the regulatory requirements of the FDA. He has over 25 years of experience in the pharmaceutical industry. Stephen Lowes is Senior Scientific Direct of Bioanalysis and ADME Services at Q2 Solutions. He earned his Ph.D. in analytical chemistry from the Open University, United Kingdom. Dr. Lowes started his industrial career at VG Biotech in the UK that became the LC/MS instrument entity of Waters Corporation. He then joined the CRO group that became Advion and focused his career on regulated bioanalysis with particular emphasis on LC/MS. He has remained very connected on regulatory developments in bioanalysis and is a founding member of the Global Bioanalysis Consortium (GBC) and a past-chair of the AAPS Bioanalytical Focus Group. Dr. Lowes has more than 40 peer reviewed publications on bioanalysis and is a frequent speaker at national and international conferences.

Introduction.- Understanding Bioanalysis Regulations.- Logistical and Operational Practice in the Regulated Bioanalysis Laboratory.- Regulated Bioanalysis: Documentation and Reports.- Historical Aspects and Key Concepts Related to its Use.- Fundamentals of LC-MS/MS for Regulated Bioanalysis.- Liquid Chromatography-Mass Spectrometry Assays in the Regulated Bioanalytical Laboratory.- Development and maintenance of critical reagents for ligand binding assays to support regulatory-compliant bioanalysis.- Ligand Binding Assays in the Regulated Bioanalytical Laboratory.