Description
John Wiley & Sons Inc Leachables And Extractables Handbook : Safety Evaluation Qualification And Best Practices Applied To Inhalation Drug Products by Edited by Douglas J. Ball , Edited by Daniel L. Norwood , Edited by Cheryl L. M. Stults , Edited by Lee M. Nagao
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.show more