International stability testing / edited by David J. Mazzo

By:

edited by Mazzo, David J

Material type: Text

TextPublication details: Illinois Interpharm Press 1999Description: 332 pISBN:

9781000122961

Subject(s):

DDC classification:

615.18 MAZ-D

Average rating: 0.0 (0 votes)

Holdings
Item type	Current library	Collection	Shelving location	Call number	Status	Date due	Barcode	Item holds
Books	BITS Pilani Hyderabad	610	General Stack (For lending)	615.18 MAZ-D (Browse shelf(Opens below))	Available		42409

Total holds: 0

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.

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