Probability of passing dissolution acceptance criteria for an immediate release tablet
作者： Monica L. Dumont , Mark R. Berry , Beverly Nickerson
DOI: 10.1016/J.JPBA.2007.01.047
关键词:
摘要: … are typically set based on S 1 and/or S 2 criteria. Furthermore, initial acceptance criteria used during development are almost arbitrary for an IR product. A common acceptance criterion …
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sci-hub.se 参考文章(7)
Jennifer B. Dressman, Gordon L. Amidon, Christos Reppas, Vinod P. Shah, Dissolution Testing as a Prognostic Tool for Oral Drug Absorption: Immediate Release Dosage Forms Pharmaceutical Research. ,vol. 15, pp. 11- 22 ,(1998) , 10.1023/A:1011984216775
Yi Tsong, Thomas Hammerstrom, Karl Lin, Ting Eng Ong, Dissolution test acceptance sampling plans. Journal of Biopharmaceutical Statistics. ,vol. 5, pp. 171- 183 ,(1995) , 10.1080/10543409508835106
James E. Polli, G. Singh Rekhi, Larry L. Augsburger, Vinod P. Shah, Methods to Compare Dissolution Profiles and a Rationale for Wide Dissolution Specifications for Metoprolol Tartrate tablets Journal of Pharmaceutical Sciences. ,vol. 86, pp. 690- 700 ,(1997) , 10.1021/JS960473X
Walter W. Hauck, Thomas Foster, Eric Sheinin, Todd Cecil, William Brown, Margareth Marques, Roger L. Williams, Oral dosage form performance tests: new dissolution approaches. Pharmaceutical Research. ,vol. 22, pp. 182- 187 ,(2005) , 10.1007/S11095-004-1184-4
Sheldon M Ross, Sheldon M Ross, Sheldon M Ross, Sheldon M Ross, Etats-Unis Mathématicien, A First Course in Probability ,(1976)
Jen-Pei Liu, Shein-Chung Chow, Michael D. Hale, Carol A. Francisco, Russell L. Reeve, Statistical Design And Analysis In Pharmaceutical Science ,(2018)
Jeffrey D. Hofer, Vivian A. Gray, Examination of Selection of Immediate Release Dissolution Acceptance Criteria Dissolution Technologies. ,vol. 10, pp. 16- 20 ,(2003) , 10.14227/DT100103P16