Leachables and Extractables Handbook (ePub)
Safety Evaluation, Qualification, and Best Practices Applied to Inhalation Drug Products
(Sprache: Englisch)
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...
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...
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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.
Autoren-Porträt
DOUGLAS J. BALL is a board-certified toxicologist (Diplomateof the American Board of Toxicology) and currently employed by
Pfizer Inc. as a Research Fellow in drug safety R&D
specializing in regulatory strategy and compliance. He chairs the
Extractables and Leachables Safety Information Exchange (ELSIE)
Board of Directors, and the Toxicology Team of the Product Quality
Research Institute (PQRI) Leachables and Extractables Working Group
for both OINDP and parenteral and ophthalmic drug products.
DANIEL L. NORWOOD is a Distinguished Research Fellow in
Analytical Development at Boehringer Ingelheim and has more than
thirty-five years of professional experience. He chaired the PQRI
Leachables and Extractables Working Group and is a thirty-two-year
member of the American Chemical Society (ACS). Dr. Norwood is a
member of the ELSIE Board of Directors.
CHERYL L. M. STULTS is a Senior Fellow at Novartis
Pharmaceuticals Corporation, focusing on materials analysis and
characterization. She chairs the International Pharmaceutical
Aerosol Consortium on Regulation and Science (IPAC-RS) Materials
and Leachables and Extractables Working Groups and is a member of
the ELSIE Board of Directors. Dr. Stults is a thirty-three year
member of the ACS.
LEE M. NAGAO is a Senior Science Advisor in the
Pharmaceutical Practice Group at Drinker Biddle & Reath LLP. As
a member of the IPAC-RS Secretariat, Dr. Nagao supports the
Consortium's initiatives in materials quality, leachables and
extractables, supplier quality, and foreign particles. She was a
member of the PQRI OINDP Leachables and Extractables Working Group
and serves as Science Advisor and Secretariat to the ELSIE
Consortium. Dr. Nagao is a member of the ACS and the AAAS.
Bibliographische Angaben
- 2012, 1. Auflage, 700 Seiten, Englisch
- Herausgegeben: Douglas J. Ball, Daniel L. Norwood, Cheryl L. M. Stults, Lee M. Nagao
- Verlag: John Wiley & Sons
- ISBN-10: 1118147685
- ISBN-13: 9781118147689
- Erscheinungsdatum: 08.02.2012
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eBook Informationen
- Dateiformat: ePub
- Grösse: 17 MB
- Mit Kopierschutz
Sprache:
Englisch
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