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The Handbook offers a practical and science-based approach for addressing toxicological concerns related to leachables and extractables associated with inhalation drug products, including metered dose inhalers, dry powder inhalers and nasal spray. Such products pose potential safety risks from leachables and extractables, chemicals that can be released or migrate from these components into the drug product. The Handbook offers 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.
Chapters where West authors contributed include:
For more information or to purchase a copy of the Handbook, visit: http://www.wiley.com/WileyCDA/WileyTitle/productCd-0470173653.html