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Books > Medicine > Other branches of medicine > Pharmacology
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International Stability Testing (Hardcover)
Loot Price: R5,185
Discovery Miles 51 850
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International Stability Testing (Hardcover)
Expected to ship within 12 - 17 working days
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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 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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