Specification of Drug Substances and Products: Development and Validation of Analytical Methods, Second Edition, presents a comprehensive and critical analysis

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

Examining the implications and practical implementation of multi-disciplinary International Conference on Harmonization (ICH) topics, this book gives an integra

This volume treats the three main categories of Statistical Quality Control: General Aspects of SQC Methodology, On-line Control including Sampling Plans, Contr

Specification of Drug Substances and Drug Products is a fully comprehensive reference on Specification Setting for Pharmaceuticals. There have been several rece