Andrew Teasdale – ICH Quality Guidelines (2018)

4.475 ₽

Автор: Andrew Teasdale
Название книги: ICH Quality Guidelines (2018)
Формат: PDF
Тема: Фармакология, Управление и экономика фармации, Стратегическое планирование в фармации, развитие продаж лекарственных средств
Страницы: 721
Качество: Изначально компьютерное, E-book

Examining the implications and practical implementation of multi-disciplinary International Conference on Harmonization (ICH) topics, this book gives an integrated view of how the guidelines inform drug development strategic planning and decision-making.

• Addresses a consistent need for interpretation, training, and implementation examples of ICH guidelines via case studies
• Offers a primary reference point for practitioners addressing the dual challenge of interpretation and practical implementation of ICH guidelines
• Uses case studies to help readers understand and apply ICH guidelines
• Provides valuable insights into guidelines development, with chapters by authors involved in generating or with experience implementing the guidelines
• Includes coverage of stability testing, analytical method validation, impurities, biotechnology drugs and products, and good manufacturing practice (GMP)