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Following an overview of analytical method validation and a discussion of its various components, the author dedicates a complete chapter to each step of validation: Templates and examples for Methods Validation Standard Operating Procedures, Standard Test Methods, Methods Validation Protocols, and Methods Validation Reports are all provided.

Moreover, the guide features detailed flowcharts and checklists that lead readers through every stage of method validation to ensure success.

Each chapter clearly guides the reader through the processes — a blueprint for how to do what you need to do.

Listed below are those e-journal titles, e-book titles, and d-collections that are committed to the Portico archive.

All of the templates are also included on a CD-ROM, enabling readers to easily work with and customize them.

This guide focuses on high-performance liquid chromatographic methods validation; however, the concepts are generally applicable to the validation of other analytical techniques as well.

0471741477 Validating chromatographic methods; a practical guide. Wiley-Interscience 2006 291 pages .00 Hardcover QD79 A consultant to the pharmaceutical industry on good manufacturing practices, Bliesner explains how an analytical laboratory can demonstrate that their chromatographic techniques are suitable for the use they are being put to.

He focuses on high-performance liquid chromatography, the most common technique used in modern pharmaceutical analytical research and development and quality control, but he says the validation process could be applied to a wide range of analytical techniques.

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