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The first part of this book deals with the application of new technology to pharmaceutical and biomedical analysis, reflecting the present needs for increased speed, sensitivity and selectivity in the analysis of drugs. The second chapter provides an overview of capillary electophoresis, which represents one of the most inportant analytical developments to impact directly on pharmaceutical development in recent years. Although not a chromatographic technique, capillary electrophoresis was considered too important to be ignored.
Over the last 25 years, liquid chromatography has grown into a mature analytical technique and many of the fundamental issues concerned with retention and separation are well defined. The practitioners of modern liquid chromatography spend as much time in the development of techniques for sampling handling and automation as they do in the development of the separation. Therefore, Part Two of this book describes some of the recent advances in the areas of sample handling and the isolation of compounds from biological samples, including solid phase extraction, restricted access media for direct injection, coupled column technology and microdialysis. Similarily, Part Three contains two chapters concerned with liquid chromatographic methods for the isolation of drug substances, peptides and proteins from other complex media.
The pharmaceutical industry and the process of drug development are highly regulated and the increasing importance that the regulatory authorities attach to validation has had a significant impact on the analytical techniques used for the analysis of drugs. Although this has increased the workload of analysts in the pharmaceutical industry, it has also improved the quality of analytical methods used in the support of investigational and new drug applications as well as the quality of methods published more recently in the literature. Consequently, Part Four of this volume describes approaches to the optimization and validation of liquid chromatography methods for the analysis of drugs in the bulk form, in pharmaceutical formulations and biological fluids.
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Dr Riley is President, Riley and Rabel Consulting Services, Inc. He received a bachelor’s degree in pharmacy (1977) and PhD degree in Pharmaceutical Chemistry (1980) from the University of Bath, England. He was a post-doctoral fellow at the University of Kansas in the Department of Pharmaceutical Chemistry (1981-1982) before joining the faculty of the Department of Pharmaceutics at the University of Florida. He returned to the University of Kansas as faculty member in 1986 where he remained until 1994. He was Vice President and Head of Analytical R&D at Dupont Pharmaceuticals (previously Dupont Merck) from 1994 to 2001. He joined ALZA 2001, a subsidiary of Johnson & Johnson, where he had positions of increasing responsibility up to Vice President and West Coast Site Head ChemPharm Development. He left ALZA in May 2007 to form Riley and Rabel Consulting Services, Inc., which provides consulting services to the Pharmaceutical and Biotechnology Industries, specializing in Analytical and Pharmaceutical Development, CMC Strategy, Organizational and Managerial Effectiveness and Patent Litigation. He has co-authored more than 140 book chapters and papers in peer-reviewed journals, as well as five books. He was awarded the Conference Science Award of the Royal Pharmaceutical Society of Great Britain and the Jubilee Medal of the Chromatographic Society. He was elected Fellow of the American Association of Pharmaceutical Scientists (AAPS) and served as the chair of the Analysis and Pharmaceutical Quality Section of AAPS and a Member of the AAPS Executive Committee. Dr. Riley has served as member and chair of the PhRMA Analytical Technical Committee (ATC), as well as a member and chair of the PhRMA Technical Leadership Committee (TLC). Dr. Riley represented PhRMA on the ICH Expert Working Group on Impurities in Drug Substances (Q3A) and Drug Products (Q3B) and was Chair of the PhRMA Working Group on Genotoxic Impurities.
