Leachables and Extractables Handbook : Safety Evaluation, Qualification, and Best Practices Applied to Inhalation Drug Products
A practical and science-based approach for addressing toxicological concerns related to leachables and extractables associated with inhalation drug products
Packaging and device components of Orally Inhaled and Nasal Drug Products (OINDP)--such as metered dose inhalers, dry powder inhalers, and nasal sprays--pose potential safety risks from leachables and extractables, chemicals that can be released or migrate from these components into the drug product. Addressing the concepts, background, historical use, and development of safety thresholds and their utility for qualifying leachables and extractables in OINDP, the Leachables and Extractables Handbook takes a practical approach to familiarize readers with the recent recommendations for safety and risk assessment established through a joint effort of scientists from the FDA, academia, and industry. Coverage includes best practices for the chemical evaluation and management of leachables and extractables throughout the pharmaceutical product life cycle, as well as.
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January 01, 2012
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