ICH Quality Guidelines: An Implementation Guide (PDF)


Format : Publisher PDF

This book provides an integrated view of how International Conference on Harmonization (ICH) guidelines inform drug development strategic planning and decision-making through the use of case studies. It covers topics such as stability testing, analytical method validation, impurities, biotechnology drugs and products, and good manufacturing practice (GMP). The eBook has 736 pages and was published by Wiley in October 2017. ISBN-10: 1118971116, ISBN-13: 978-1118971116.

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