International Stability Testing

By Mazzo J. Mazzo

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 initiative, matrixing and bracketing approaches from the cGMP and FDA perspective, and stability requirements in Japan, Australia, and WHO. Stress programs, testing of preservatives, and physical stability topics are addressed as well as various protocols and statistical approaches.

• Format: Hardcover
• Language: English
• ISBN: 1574910787
• ISBN13: 9781574910780
• Release Date: August 1998
• Publisher: CRC Press
• Length: 350 Pages
• Weight: 1.77 lbs.
• Dimensions: 1.0" x 7.0" x 10.5"