Leachables and Extractables Handbook

This book PDF is perfect for those who love Science genre, written by Douglas J. Ball and published by John Wiley & Sons which was released on 24 January 2012 with total hardcover pages 702. You could read this book directly on your devices with pdf, epub and kindle format, check detail and related Leachables and Extractables Handbook books below.

Leachables and Extractables Handbook
Author : Douglas J. Ball
File Size : 44,6 Mb
Publisher : John Wiley & Sons
Language : English
Release Date : 24 January 2012
ISBN : 9780470173657
Pages : 702 pages
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Leachables and Extractables Handbook by Douglas J. Ball Book PDF Summary

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.

Leachables and Extractables Handbook

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,

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