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Good Cascade Impactor Practices, AIM and EDA for Orally Inhaled Products. 2013 ed.
・ISBN 978-1-4614-6295-8 hard EUR 149.99
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| 著者・編者 | Tougas, Terrence P. / Mitchell, Jolyon P. / Lyapustina, Svetlana A. (eds.), |
|---|---|
| 出版社 | (Springer-Verlag New York Inc., US) |
| 出版年月 | 2013 |
| ページ数 | 442 pp. |
| 言語 | ENG |
| ニュース番号 | ＜A05-46034＞ |
解説
The purpose of this publication is to introduce a new, simpler and more effective way in which to interpret pharmaceutical aerosol particle size data from orally inhaled products (OIPs). Currently, the compendial and regulatory requirements dictate the need for measurements by full resolution multi-stage cascade impactor (CI), a process that is demanding for the operator, time consuming, prone to experimental error, and challenging for method transfers from one laboratory to another. Furthermore, we shall show that the current practice of reducing information from mass-weighted aerodynamic particle size distribution (APSD) measurements through the use of CI stage groupings is not the most effective decision-making tool for OIP quality control (QC) in comparison with newly introduced, mutually-independent efficient data analysis (EDA) metrics that can be derived either from full resolution or abbreviated impactor measurements (AIM).