qBecause 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 analysisq--Provided by publisher.Prioritization of specific aspects of the methodology can be assisted by using an Ishikawa diagram/FMEA approach as ... produces an optimal experimental output , for example, maximum signal, minimum background, minimal degradation, ... An alternate approach to method development is multivariate and involves examining multiple factors at one time with a design of experiment (DOE).48, 49 Typically, anbsp;...
|Title||:||Leachables and Extractables Handbook|
|Author||:||Douglas J. Ball, Cheryl L. M. Stults, Lee M. Nagao|
|Publisher||:||John Wiley & Sons - 2012-01-24|