An Application of X-Ray Fluorescence as Process Analytical Technology (PAT) to Monitor Particle Coating Processes
Author:
Affiliation:
1. Research and Development Department, Zensei Pharmaceutical Co., Ltd.
2. Production Technology Department, Manufacturing Division, Shionogi & Co., Ltd.
3. Manufacturing Science & Technology, AstraZeneca K.K.
Publisher
Pharmaceutical Society of Japan
Subject
Drug Discovery,General Chemistry,General Medicine
Link
https://www.jstage.jst.go.jp/article/cpb/66/6/66_c17-00906/_pdf
Reference20 articles.
1. 1) FDA, “Pharmaceutical cGMPs for the 21st Century—A Risk-Based Approach,” Final Report, September 2004.
2. 2) ICH Guidelines: Q8 (R2) Pharmaceutical Development (August 2009), Q9 Quality Risk Management (November 2005) and Q10 Pharmaceutical Quality System (June 2008).
3. 3) FDA, Guidance for Industry: “PAT-A Framework for Innovative Pharmaceutical Development, Manufacturing and Quality Assurance,” September 2004.
4. 4) Bakeev K., “Process Analytical Technology: Spectroscopic Tools and Implementation Strategies for the Chemical and Pharmaceutical Industries,” Wiley, New York, 2010
5. 5) Reich G., Adv. Drug Deliv. Rev., 57, 1109–1143 (2005).
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