Leachables and Extractables Handbook
Safety Evaluation, Qualification, and Best Practices Applied to Inhalation Drug Products
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…
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Produktdetails
Weitere Autoren: Ball, Douglas J. (Hrsg.) / Stults, Cheryl L. M. (Hrsg.) / Norwood, Daniel L. (Hrsg.)
- ISBN: 978-1-118-14770-2
- EAN: 9781118147702
- Produktnummer: 13856717
- Verlag: Wiley
- Sprache: Englisch
- Erscheinungsjahr: 2011
- Seitenangabe: 700 S.
- Plattform: PDF
- Masse: 16'337 KB
Über den Autor
DOUGLAS J. BALL is a board-certified toxicologist (Diplomate of 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.
1 weiteres Werk von Lee M. (Hrsg.) Nagao:
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