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International Stability Testing |  | Creator: David J. Mazzo
Publisher: Informa Healthcare
Category: Book
List Price: $299.95
Buy Used: $174.93
as of 3/21/2010 06:32 MDT details
You Save: $125.02 (42%)
Seller: kitchi-gummi
Sales Rank: 2781471
Media: Hardcover
Edition: 1
Pages: 352
Number Of Items: 1
Shipping Weight (lbs): 2
Dimensions (in): 10.5 x 7.1 x 1.1
ISBN: 1574910787
Dewey Decimal Number: 615.18
EAN: 9781574910780
ASIN: 1574910787
Publication Date: August 31, 1998
Availability: Usually ships in 1-2 business days
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Product Description
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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