The editors have engaged leading scientists in the field to participate in the development of this book, which is envisioned as a one of a kind contribution to the field.? The book is a comprehensive text that puts fundamental bioanalytical science in context with current practice, its challenges and ongoing developments. It expands on existing texts on the subject by covering regulated bioanalysis of both small and large molecule therapeutics from both a scientific and regulatory viewpoint. The ?content will be useful to a wide spectrum of readers: from those new to bioanalysis; to those developing their experience in the laboratory, or working in one of the many critical supporting roles; to seasoned practitioners looking for a solid source of information on this exciting and important discipline. ?
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.
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 Pharmaceuticall3/
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