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Leachables and Extractables Handbook

Safety Evaluation, Qualification, and Best Practices Applied to Inhalation Drug Products

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Éditeur :

Wiley


Paru le : 2012-02-08



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Description

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.
Pages
700 pages
Collection
n.c
Parution
2012-02-08
Marque
Wiley
EAN papier
9780470173657
EAN PDF
9781118147702
Informations sur l'ebook
Nombre pages copiables
0
Nombre pages imprimables
700
Taille du fichier
16333 Ko
Ce livre est accessible aux handicaps Voir les informations sur l'accessibilité
Prix
152,92 €
EAN EPUB
9781118147689
Informations sur l'ebook
Nombre pages copiables
0
Nombre pages imprimables
700
Taille du fichier
17439 Ko
Ce livre est accessible aux handicaps Voir les informations sur l'accessibilité
Prix
152,92 €

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