Written for practitioners in both the drug and biotechnology industries, this handbook carefully compiles current regulatory requirements on the validation of new or modified analytical methods. Shedding light on method validation from a practical standpoint, it contains practical, up-to-date guidelines for analytical method validation. It also covers development, optimization, validation, and transfer of many different types of methods used in the regulatory environment. Simplifying 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 the biotech industry.

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.

The first book to focus entirely on reactions for analyte detection and characterization,Reaction Detection in Liquid Chromatography depicts off- and on-line, pre- and postcolumnapproaches that have been successfully used for many classes of compounds, bothorganic and inorganic, in high performance liquid chromatography.The book gives special attention to methods and instrumentation associated with postcolumnreaction detection, discussing theory, background, principles, and equations .. .and also highlights major areas of reaction chemistry, such as immobilized ( or solution)enzymatic reactions, homogenous solution chemistry, photochemical derivation, pairedionreagents, solid phase and solid supported reagents, and reactions for inorganic species.In addition, Reaction Detection in liquid Chromatography details the efficiencies of thevarious reactions surveyed ... forecasts how the utility of each reaction is likely to be enhancedby new research ... and gives data that will allow the reader to reproducereaction-detection approaches for new analytes and samples.Reaction Detection in Liquid Chromatography is essential reading for analytical, bioanalytical,quality control, and research and development chemists. It also comprises a finereference for analysts involved in development and applications of liquid chromatographyfor specific qualitative and quantitative analyte identification; and in-house, professionalseminars.

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 validation Summarizes the latest regulatory requirements for all aspects of method validation, even those coming from the USP, but undergoing modifications Covers development, optimization, validation, and transfer of many different types of methods used in the regulatory environment Simplifying 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.

The alarm sounded by Canada's recently confirmed case of bovine spongiform encephalopathy (BSE) has reaffirmed the exigency of establishing improved safeguards and more aggressive surveillance protocols in North America and around the world. Research converging on the probable causative agent-prion proteins-calls for intensive assessment of the headway gained in tracing prions, testing for transmissible neurodegenerative diseases, and developing methods for cornering the epidemic. Administered by an illustrious panel of 36 international contributors, this timely book marshals techniques for prion protein assay and diagnosis of transmissible spongiform encephalopathies (TSEs).