Michael E. Swartz - Böcker

Describes analytical methods development, optimization and validation, and provides examples of successful methods development and validation in high-performance liquid chromatography (HPLC) areas. The text presents an overview of Food and Drug Administration (FDA)/International Conference on Harmonization (ICH) regulatory guidelines, compliance with validation requirements for regulatory agencies, and methods validation criteria stipulated by the US Pharmacopia, FDA and ICH.

Written for practitioners in both the drug and biotechnology industries, the Handbook of Analytical Validation carefully compiles current regulatory requirements on the validation of new or modified analytical methods. Shedding light on method validation from a practical standpoint, the handbook: Contains practical, up-to-date guidelines for analytical method validationSummarizes the latest regulatory requirements for all aspects of method validation, even those coming from the USP, but undergoing modificationsCovers development, optimization, validation, and transfer of many different types of methods used in the regulatory environmentSimplifying the overall process of method development, optimization and validation, the guidelines in the Handbook apply to both small molecules in the conventional pharmaceutical industry, as well as well as the biotech industry.

This volume presents the necessary tools for developing methods and analyzing results in the drug discovery process, and supports documenting and managing the process in a combinatorial setting. It describes the chromatographic and spectroscopic techniques used to generate chemical and molecular diversity in new compounds, focusing on applications of information management systems, instrumentation, and robotics.

Describes analytical methods development, optimization and validation, and provides examples of successful methods development and validation in high-performance liquid chromatography (HPLC) areas. The text presents an overview of Food and Drug Administration (FDA)/International Conference on Harmonization (ICH) regulatory guidelines, compliance with validation requirements for regulatory agencies, and methods validation criteria stipulated by the US Pharmacopia, FDA and ICH.