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International Stability Testing

David J. Mazzo
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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.
      Format: Hardback CONTRIBUTORS: David J. Mazzo EAN: 9781574910780 COUNTRY: United States PAGES: WEIGHT: 810 g HEIGHT: 254 cm
      PUBLISHED BY: Taylor & Francis Inc DATE PUBLISHED: 1998-08-31 CITY: GENRE: BUSINESS & ECONOMICS / Industries / Pharmaceutical & Biotechnology, MEDICAL / Drug Guides, MEDICAL / Pharmacology, SCIENCE / Chemistry / General WIDTH: 178 cm SPINE:

      Book Themes:

      Medicine: general issues, Biology, life sciences, Pharmaceutical chemistry and technology

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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.
      Format: Hardback CONTRIBUTORS: David J. Mazzo EAN: 9781574910780 COUNTRY: United States PAGES: WEIGHT: 810 g HEIGHT: 254 cm
      PUBLISHED BY: Taylor & Francis Inc DATE PUBLISHED: 1998-08-31 CITY: GENRE: BUSINESS & ECONOMICS / Industries / Pharmaceutical & Biotechnology, MEDICAL / Drug Guides, MEDICAL / Pharmacology, SCIENCE / Chemistry / General WIDTH: 178 cm SPINE:

      Book Themes:

      Medicine: general issues, Biology, life sciences, Pharmaceutical chemistry and technology

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      Be the first to write a review
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