Performance Characterization of EDA and Its Potential to Improve Decision Making in Product Batch Release
In this chapter, APSD data are examined from real products using several different strategies to compare the ability of EDA to detect APSD changes with grouped stages from full-resolution CI measurements. These comparisons were made relative to decision m
- PDF / 19,262,037 Bytes
- 443 Pages / 439.42 x 683.15 pts Page_size
- 34 Downloads / 174 Views
Good Cascade Impactor Practices, AIM and EDA for Orally Inhaled Products
Good Cascade Impactor Practices, AIM and EDA for Orally Inhaled Products
Terrence P. Tougas • Jolyon P. Mitchell Svetlana A. Lyapustina Editors
Good Cascade Impactor Practices, AIM and EDA for Orally Inhaled Products
Editors Terrence P. Tougas Analytical Development Boehringer Ingelheim Pharmaceuticals Inc. Ridgefield, CT, USA
Jolyon P. Mitchell Trudell Medical International London, ON, Canada
Svetlana A. Lyapustina Drinker Biddle & Reath LLP Washington, DC, USA
ISBN 978-1-4614-6295-8 ISBN 978-1-4614-6296-5 (eBook) DOI 10.1007/978-1-4614-6296-5 Springer New York Heidelberg Dordrecht London Library of Congress Control Number: 2013932873 © Springer Science+Business Media New York 2013 This work is subject to copyright. All rights are reserved by the Publisher, whether the whole or part of the material is concerned, specifically the rights of translation, reprinting, reuse of illustrations, recitation, broadcasting, reproduction on microfilms or in any other physical way, and transmission or information storage and retrieval, electronic adaptation, computer software, or by similar or dissimilar methodology now known or hereafter developed. Exempted from this legal reservation are brief excerpts in connection with reviews or scholarly analysis or material supplied specifically for the purpose of being entered and executed on a computer system, for exclusive use by the purchaser of the work. Duplication of this publication or parts thereof is permitted only under the provisions of the Copyright Law of the Publisher's location, in its current version, and permission for use must always be obtained from Springer. Permissions for use may be obtained through RightsLink at the Copyright Clearance Center. Violations are liable to prosecution under the respective Copyright Law. The use of general descriptive names, registered names, trademarks, service marks, etc. in this publication does not imply, even in the absence of a specific statement, that such names are exempt from the relevant protective laws and regulations and therefore free for general use. While the advice and information in this book are believed to be true and accurate at the date of publication, neither the authors nor the editors nor the publisher can accept any legal responsibility for any errors or omissions that may be made. The publisher makes no warranty, express or implied, with respect to the material contained herein. Printed on acid-free paper Springer is part of Springer Science+Business Media (www.springer.com)
Preface
The measurement of the aerodynamic size properties of aerosols from orally inhaled products has been a long-standing topic of interest to stakeholders because of the need to provide measurements that can ultimately be related to the likely deposition in the human respiratory tract and therefore to subsequent clinical response to the active pharmaceutical ingredient(s). The challenge has been the limited choice of measurement equipment available tha
Data Loading...
