Leachables And Extractables Handbook Hardcover 1st

Douglas J. Ball

Because leachables are non-drug-related impurities, there are increased concerns regarding the risks of inhaling them on a daily basis. This book describes the development and application of safety thresholds for Orally Inhaled and Nasal Drug Products (OINDP). It discusses best practices for evaluation and management of leachables and extractables throughout the pharma product lifecycle by providing practical knowledge about how and why safety thresholds were developed. This book also illustrates how to apply these concepts and principles to products beyond OINDP, and includes an appendix of experimental protocols for laboratory analysis.

0470173653

9780470173657

English

Wiley-Blackwell

20-Feb-2012

700

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.

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