International Stability Testing (inbunden)
Format
Inbunden (Hardback)
Språk
Engelska
Antal sidor
352
Utgivningsdatum
1998-08-01
Förlag
CRC Press Inc
Medarbetare
Mazzo, David J. (red.)
Illustratör/Fotograf
illustrations
Illustrationer
illustrations
Dimensioner
266 x 179 x 24 mm
Vikt
804 g
Antal komponenter
1
Komponenter
,
ISBN
9781574910780
International Stability Testing (inbunden)

International Stability Testing

Inbunden Engelska, 1998-08-01
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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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Innehållsförteckning

ICH Stability Guidelines. Photostability Testing. ICH Guidelines for Biological & Biotechnological Products. Stress Testing: Drug Substance Characterization. Statistical & Regulatory Aspects: FDA Perspective. Matrixing & Bracketing Designs: European Perspective. Preservative Activity During Studies. Substances Solid-State Characterization & Stability. Europe: Requirements. Postapproval FDA Requirements. Japan. Australia. WHO. Non-ICH Areas.