Leachables and Extractables Handbook Safety Evaluation, Qualification, and Best Practices Applied to Inhalation Drug Products
Leachables and Extractables Handbook Safety Evaluation, Qualification, and Best Practices Applied to Inhalation Drug Products
- ISBN 13:
9780470173657
- ISBN 10:
0470173653
- Edition: 1st
- Format: Hardcover
- Copyright: 01/24/2012
- Publisher: Wiley
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Summary
Because leachables are non-drug-related impurities, there is an increased concern for human risk by inhaling them on a daily basis. Recently, however, safety thresholds for leachables have been developed by the FDA, academia, and industry. This book addresses concepts, background, historical use, and development of safety thresholds and their utility for qualifying leachables in Orally Inhaled and Nasal Drug Products (OINDP). Coverage includes the FDA and EU regulatory perspectives concerning leachables in OINDP. While written specifically for OINDP, the principles outlined can be applied to leachables qualification in other drug products.