Leachables and Extractables Handbook Safety Evaluation, Qualification, and Best Practices Applied to Inhalation Drug Products
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Form:Einzelkauf Download
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Sprache:Englisch
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eBook Format:PDF
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134,99 €
inkl. gesetzl. MwSt.Beschreibung
Produktdetails
Format
Kopierschutz
Ja
Family Sharing
Nein
Text-to-Speech
Nein
Erscheinungsdatum
09.06.2011
Herausgeber
Douglas J. Ball + weitereVerlag
John Wiley & SonsSeitenzahl
700 (Printausgabe)
Dateigröße
16337 KB
Auflage
1. Auflage
Sprache
Englisch
EAN
9781118147702
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.
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.
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