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Describes analytical methods development, optimization and validation, and provides examples of successful methods development and validation in high-performanc

The need to validate an analytical or bioanalytical method is encountered by analysts in the pharmaceutical industry on an almost daily basis, because adequatel

Validation describes the procedures used to analyze pharmaceutical products so that the data generated will comply with the requirements of regulatory bodies of

Adopting a practical approach, the authors provide a detailed interpretation of the existing regulations (GMP, ICH), while also discussing the appropriate calcu

Written for practitioners in both the drug and biotechnology industries, this handbook carefully compiles the current regulatory requirements to correctly and p