Items related to International Stability Testing

International Stability Testing - Hardcover

 
9781574910780: International Stability Testing
Hardcover
ISBN 10: 1574910787 ISBN 13: 9781574910780
Publisher: CRC Press, 1998

Synopsis

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.

"synopsis" may belong to another edition of this title.

About the Author

David J. Mazzo

From the Back Cover

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.

"About this title" may belong to another edition of this title.

Publisher
CRC Press
Publication date
1998
Language
English
ISBN 10 
1574910787
ISBN 13 
9781574910780
Binding
Hardcover
Edition number
1
Number of pages
350
Editor
Mazzo David J.