Handbook of analytical validation
著者
書誌事項
Handbook of analytical validation
CRC Press, Taylor & Francis Group, 2012
- hardback
大学図書館所蔵 全2件
注記
Includes bibliographical references and index
内容説明・目次
内容説明
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.
目次
Introduction to Analytical Method Validation. Analytical Instrument Qualification. HPLC Method Development and Optimization with Validation in Mind. Method Validation Basics. Robustness and System Suitability. Setting Specifications and Investigating Out-of-Specification Results. Validation by Type of Method. Analytical Method Transfer. Implementing New Technology in a Regulated Environment. Glossary of Terms Related to Chromatographic Method Validation.
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