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

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

This book provides a comprehensive guide on validating analytical methods. Key features: Full review of the available regulatory guidelines on validation and in

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