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 Review "The analogy of extractables and leachables to the bogeyman hiding in the closet is so true and telling, whether experienced with leachable studies or not the issues are well communicated. Nomenclature is established, in the author?s vernacular, which describes pharmaceutical contact materials and key terms enabling a clear understanding of the objectives of compatibility assessments. Excellent examples of extractables studies, correlations and risk assessments are given and the classification of extraction strategies puts into perspective the purpose for acquiring the data. The appendix listing materials and their associated extractables is a valuable reference tool for chemists, toxicologists and regulators involved with qualifying contact materials used with pharmaceutical products. This is a comprehensive and practical guide for both the novice and the knowledgeable. A great read!" --Diane M. Paskiet, Associate Director of Scientific Affairs, West Pharmaceutical Services Product Description Compatibility of Pharmaceutical Products and Contact Materials Dennis Jenke Important safety aspects of compatibility for therapeutic products and their manufacturing systems, delivery devices, and containers Compatibility of Pharmaceutical Products and Contact Materials helps pharmaceutical, toxicology, analytical, and regulatory affairs professionals assess the safety of leachable and extractable chemicals associated with drug product packaging, manufacturing systems Read more...
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