Leachables and Extractables Handbook (Innbundet)

Safety Evaluation, Qualification, and Best Practices Applied to Inhalation Drug Products

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Innbinding: Innbundet
Utgivelsesår: 2012
Antall sider: 700
Forlag: John Wiley and Sons Ltd
Språk: Engelsk
ISBN/EAN: 9780470173657
Omtale: Leachables and Extractables Handbook
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.

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