International Stability Guidelines
Book Details
Format
Hardback or Cased Book
ISBN-10
1574910787
ISBN-13
9781574910780
Publisher
Taylor & Francis Inc
Imprint
CRC Press Inc
Country of Manufacture
US
Country of Publication
GB
Publication Date
Aug 31st, 1998
Print length
350 Pages
Weight
810 grams
Dimensions
18.60 x 25.70 x 2.60 cms
Product Classification:
Medical researchPharmacologyPharmacologyPharmacy / dispensing
Ksh 37,800.00
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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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