ICH Quality Guidelines: An Implementation Guide (EPUB)

This book examines the practical implementation and implications of multi-disciplinary International Conference on Harmonization (ICH) topics in drug development strategic planning and decision-making. It provides valuable insights into guidelines development, utilizing case studies to help readers understand and apply ICH guidelines. The book serves as a primary reference point for practitioners facing the challenge of interpreting and implementing ICH guidelines, with chapters written by authors that are involved in generating or have experience implementing the guidelines. In addition, the book covers stability testing, analytical method validation, impurities, biotechnology drugs and products, and good manufacturing practice (GMP).