Overview

This text is intended to serve as a guide to the analyst in terms of the issues and parameters that must be considered in the development and validation of analytical methods. It also deals with other related factors such as method development, data acquisition, automation and cleaning validation. It is divided into three parts. Part one looks at some of the basic concepts of method validation. Part two focuses on the regulatory perspective of analytical validation, while part three covers the development and validation of various analytical components of the pharmaceutical product development process. This text is not intended to be a practical description of the analytical validation process, but more of a guide to the critical parameters and considerations that must be attended to in a pharmaceutical development programme. It brings together the perspectives of several experts with experience in different capacities in the pharmaceutical industry in an attempt to bring some consistency to analytical method development and validation.

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9780080427928

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G.P. Carr ...this book contains a great deal of material on applications of analytical methods which should be very valuable to analytical chemists employed within the pharmaceutical industry. Analyst

G.P. Carr ...this book contains a great deal of material on applications of analytical methods which should be very valuable to analytical chemists employed within the pharmaceutical industry. Analyst

G.P. Carr...this book contains a great deal of material on applications of analytical methods which should be very valuable to analytical chemists employed within the pharmaceutical industry.Analyst

Author Information

Dr. Christopher Riley is the President of Riley and Rabel Consulting Services. He received a bachelor’s degree in Pharmacy (1977) and PhD degree in Pharmaceutical Chemistry (1980) from the University of Bath, UK. He taught Pharmaceutical Chemistry, at the Universities of Florida (1983-6) and the University of Kansas (1986-94), and was a Vice President at DuPont Merck (1994-2001) and ALZA (a division of J&J) (2001-7). He has coauthored more than 140 book chapters and papers in peer-reviewed journals, as well as 5 books. He has extensive experience in CMC regulatory affairs and the development of all types of dosage forms. Former Director of Business Development at Acceleration Laboratory Services, Incorporated. He has previously held scientific and senior management positions at The Upjohn Company, Marion Laboratories, Marion Merrell Dow, Hoechst Marion Roussel, Quintiles, Eli Lilly, Beckloff Associates, and PPD. He currently serves on a Small Molecule USP Expert Committee.

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