Reliability Evaluation of the Design Space of the Granulation Process of Mefenamic Acid Tablets Using a Bootstrap Resampling Technique
Author:
Affiliation:
1. Formulation Technology Research Laboratories, Daiichi Sankyo Co., Ltd.
2. Research and Development Headquarters, Yamatake Corporation
3. Department of Pharmaceutics, Hoshi University
Publisher
Pharmaceutical Society of Japan
Subject
Drug Discovery,General Chemistry,General Medicine
Link
http://www.jstage.jst.go.jp/article/cpb/59/5/59_5_608/_pdf
Reference26 articles.
1. 1) ICH guideline, “Pharmaceutical Development Q8 (R2),” August 2009.
2. Quality by design case study: An integrated multivariate approach to drug product and process development
3. 3) Montgomery D. C., “Design and Analysis of Experiments,” John Wiley & Sons, U.S.A., 1997.
4. 4) Lewis G. A., Mathieu D., Phan-Tan-Luu R., “Pharmaceutical Experimental Design,” Marcel Dekker, New York, 1999.
5. Identification of critical formulation and processing variables for metoprolol tartrate extended-release (ER) matrix tablets1This manuscript represents the personal opinions of the authors and does not necessarily represent the views or policies of the FDA.1
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