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Leachables and Extractables Handbook: Safety Evaluation, Qualification, and Best Practices Applied to Inhalation Drug Products From Wiley
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- Sales Rank: #2029224 in Books
- Published on: 2012-01-24
- Original language: English
- Number of items: 1
- Dimensions: 9.60" h x 1.66" w x 6.60" l, 2.47 pounds
- Binding: Hardcover
- 700 pages
Review
“However, since this handbook provides clear, relevant information across both toxicology and pharmaceutical analysis/development, it is probably most useful for practicing toxicologists or chemists, providing both a detailed reference to dip into and a means of better understanding the requirements and contributions of colleagues working in the other discipline.” (British Toxicology Society, 1 July 2013)
“However, the book is extremely well written and is a compelling read. The book accomplishes its goal to provide a state of the art review with respect to mercury . . . The book serves as an excellent educational resource.” (International Journal of Toxicology, 31 May 2012) About the Author
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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