Leachables and Extractables Handbook
Subtitle: Safety Evaluation, Qualification, and Best Practices Applied to Inhalation Drug Products
Publisher: Wiley
Published: Jan 24, 2012
Language: eng
Format: hardcover
Number of pages: 700
ISBN-13: 9780470173657
Description: "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"--Provided by publisher.
Notes: Source title: Leachables and Extractables Handbook: Safety Evaluation, Qualification, and Best Practices Applied to Inhalation Drug Products