Drug Stability: ICH versus Accelerated Predictive Stability Studies

• Main Authors: Olga González-González (Author), Irving O. Ramirez (Author), Bianca I. Ramirez (Author), Peter O'Connell (Author), Maria Paloma Ballesteros (Author), Juan José Torrado (Author), Dolores R. Serrano (Author)
• Format: Book
• Published: MDPI AG, 2022-10-01T00:00:00Z.
• Subjects: article
• Online Access: Connect to this object online.

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), along with the World Health Organization (WHO), has provided a set of guidelines (ICH Q1A-E, Q3A-B, Q5C, Q6A-B) intended to unify the standards for the European Union, Japan, and the United...