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:
Guidance for pharmaceutical professionals to qualify and risk-assess container closure system leachables and extractables in drug products
Principles for defining toxicological safety thresholds that are applicable to OINDP and potentially applicable to other drug products
Regulatory perspectives, along with an appendix of key terms and definitions, case studies, and sample protocols
Analytical chemists, packaging and device engineers, formulation development scientists, component suppliers, regulatory affairs specialists, and toxicologists will all benefit from the wealth of information offered in this important text.
Less
See More Details
Description: Back to School Promotion at eBooks.com. 12% off Academic book titles. Landing page is on our academics category page. Static image.
Back to School Promotion at eBooks.com. 12% off Academic book titles. Landing page is on our academics category page. Static image.
See More Details
Description: Purchase textbooks at student discounts!
Purchase textbooks at student discounts!
Available to 2020-12-31 06:04:00
See More Details
Description: 20% Off these Categories- Body Mind & Spirit, Family & Relationships, Foreign Language Study, History, Sports & Recreation. Offer Lasts all through January.
20% Off these Categories- Body Mind & Spirit, Family & Relationships, Foreign Language Study, History, Sports & Recreation. Offer Lasts all through January.
Reflow text when sidebars are open.
