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Douglas J. Ball - Leachables and Extractables Handbook - 9780470173657 - V9780470173657
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Leachables and Extractables Handbook

€ 156.78
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Description for Leachables and Extractables Handbook Hardcover. 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). Editor(s): Ball, Douglas J.; Norwood, Daniel L.; Stults, Cheryl L. M.; Nagao, Lee M. Num Pages: 700 pages, Illustrations. BIC Classification: PN. Category: (P) Professional & Vocational. Dimension: 241 x 157 x 43. Weight in Grams: 1116.

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 ... Read more

  • 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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Product Details

Format
Hardback
Publication date
2012
Publisher
John Wiley and Sons Ltd United Kingdom
Number of pages
700
Condition
New
Number of Pages
700
Place of Publication
New York, United States
ISBN
9780470173657
SKU
V9780470173657
Shipping Time
Usually ships in 7 to 11 working days
Ref
99-50

About Douglas J. Ball
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 ... Read more

Reviews for Leachables and Extractables Handbook
“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 ... Read more

Goodreads reviews for Leachables and Extractables Handbook


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