West Authors Contribute Chapters to New Leachables and Extractables Handbook
West authors Diane Paskiet, Kim Miller, Laura Stubbs and Diego Zurbriggen contributed to several chapters in the new “Leachables and Extractables Handbook: Safety Evaluation, Qualification, and Best Practices Applied to Inhalation Drug Products” available from Wiley Scientific.
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:
- Chapter 11. Chemical and Physical Attributes of Plastics and Elastomers: Impact on the Extractables Profile of Container Closure Systems (Michael A Ruberto, Diane Paskiet and Kim Miller)
- Chapter 16: Extractables – Case Study of a Polypropylene (Diane Paskiet, Laura Stubbs, and Alan D. Hendricker)
- Chapter 20: Inorganic Leachables (Diane Paskiet, Ernest L. Lippert, Brian D. Mitchell, and Diego Zurbriggen)
For more information or to purchase a copy of the Handbook, visit: http://www.wiley.com/WileyCDA/WileyTitle/productCd-0470173653.html