ICH Quality Guidelines: An Implementation Guide (PDF Book)
Get your hands on the book titled “Multi-disciplinary Guidelines for the Implementation of ICH Topics” edited by Andrew Teasdale, David Elder, and Raymond W. Nims . This book provides an integrated view of how the guidelines inform drug development strategic planning and decision-making, while examining their implications and practical implementation.
With the use of case studies, this book addresses a consistent need for interpretation, training, and implementation examples of ICH guidelines. It offers a primary reference point for practitioners and helps them understand and apply ICH guidelines. The book also provides valuable insights into guidelines development with chapters written by authors involved in generating or with experience implementing the guidelines. The topics covered in the book include stability testing, analytical method validation, impurities, biotechnology drugs and products, and good manufacturing practice (GMP).
- eBook Digital: 200 pages
- Publisher: Wiley; 1 edition (October 9, 2017)
- Language: English
- ISBN-10: 1118971116
- ISBN-13: 978-1118971116
- Product Dimensions: 6.2 x 1.5 x 9.2 inches