Handbook of Modern Pharmaceutical Analysis

This authoratative and practical handbook highlights the role of analytical R&D through its organization of chapters on a process-driven basis. Includes coverage of: * Regulatory requirements and compliance issues * Material from the International Conference on Harmonization * New drug discovery and optimization processes based on combinatorial chemistry coupled with high-througput screening * Processes involved in developing successful formulations, including new delivery systems * The nuts and bolts of pharmaceutical analysis that generally constitutes compendial testing, method developments, setting specifications, stability studies, and method validation Additionally, the importance of excellent analytical documentation is discussed in regard to monitoring and ensuring the identity, purity, stability, and consistency of drug substance and dosage forms used during preclinical, clinical, and marketing phases in accordance with governing regulatory guidance and policies. New analytical platforms such as microfabricated electrophoresis devices are also reviewed and their applications to analysis of proteins, peptides, DNA, and small molecules, including chiral separations, are highlighted.Ahuja, Satinder is the author of 'Handbook of Modern Pharmaceutical Analysis' with ISBN 9780120455553 and ISBN 0120455552.