International Stability Testing (e-bok)
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E-bok
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PDF med LCP-kryptering (0.0 MB)
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Språk
Engelska
Antal sidor
352
Utgivningsdatum
2020-08-26
Förlag
Taylor & Francis Ltd
ISBN
9781000122961

International Stability Testing E-bok

av David J Mazzo
E-bok (PDF, LCP),  Engelska, 2020-08-26
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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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