Handbook of Analytical Validation

Written for practitioners in drug and biotechnology industries, this title is designed to teach readers how to fully and correctly adapt new or modified analytical methods to meet regulatory requirements. It offers the regulatory requirements for submitting applications for new drugs or other applications, as regards analytical method validation.

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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.