Provides the only single-volume reference for stability requirement in all major markets Discusses all aspects of stability testing, including ICH stability guidelines Supports the text with real-world examples In this book, recognized industry experts and regulatory inspectors from the world's pharmaceutical manufacturing regions provide stability requirements in all the major markets and discuss all aspects of stability testing and biotechnology. Participants in the ICH debates interpret the ICH guidelines. Other discussions focus on European requirements, the ICH initiatives, the US SUPAC...