Understanding and Implementing ICH Guidelines: A Comprehensive Guide

By Andrew Teasdale, David Elder, and Raymond W. Nims

Published by Wiley, 1st Edition, October 9, 2017

736 pages, Hardcover, ISBN-10: 1118971116, ISBN-13: 978-1118971116

Dimensions: 6.2 x 1.5 x 9.2 inches

Language: English

This comprehensive guide provides an integrated view of how the International Conference on Harmonization (ICH) guidelines inform drug development strategic planning and decision-making. It addresses a consistent need for interpretation, training, and implementation examples of ICH guidelines via case studies.

With chapters by authors involved in generating or with experience implementing the guidelines, this book offers a primary reference point for practitioners addressing the dual challenge of interpretation and practical implementation of ICH guidelines. It uses case studies to help readers understand and apply ICH guidelines, providing valuable insights into guidelines development.

The book covers essential topics such as stability testing, analytical method validation, impurities, biotechnology drugs and products, and good manufacturing practice (GMP). It serves as a practical resource for professionals in the pharmaceutical industry, regulatory bodies, and academia, helping them navigate the complex landscape of ICH guidelines and their implications for drug development.

By examining the practical implementation of multi-disciplinary ICH topics, this book aims to enhance the understanding and application of these guidelines, ultimately contributing to the improvement of drug development processes and ensuring compliance with international regulatory standards.