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: <ul>
<li>Contains practical, up-to-date guidelines for analytical method validation</li> <li>Summarizes the latest regulatory requirements for all aspects of method validation, even those coming from the USP, but undergoing modifications</li> <li>Covers development, optimization, validation, and transfer of many different types of methods used in the regulatory environment</li>
</ul>
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.

Handbook of Analytical Validation

Science & Math

Swartz, Michael E.

Krull, Ira S.

Chemistry

CRC-Press

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.

Reaction Detection in Liquid Chromatography (Chromatographic Science Series)

Routledge

Covers the theory, instrumentation, and specific uses and applications of capillary electrochromatography (CEC) and pressurized flow capillary electrochromatography (PEC). Discusses advantages and limitations of CEC/PEC compared with more conventional modes of separation and explains method development and optimization. Introducing the fundamentals and literature to those first approaching applications in CEC/PEC, the book will serve as a valuable guide for analytical chemists and biochemists, molecular biologists, immunologists, pharmaceutical scientists, and environmental and industrial chemists.

Capillary Electrochromatography and Pressurized Flow Capillary Electrochromatography

Stevenson, Robert L.

Ira S. Krull

ROBERT L. STEVENSON

Kavita Mistry

Michael E. Swartz

Mistry, Kavita

Biological Sciences

HNB Publishing

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.

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Books by Krull, Ira S.