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Dissolution test acceptance sampling plansFootnote^∗
^∗The views expressed in this paper are the authors' professional opinions. They do not represent the official of the U.S. Food and Drug Administration.

Yi Tsong Division of Biometrics, HFD-710,

Thomas Hammerstrom Division of Biometrics, HFD-710,

Karl Lin Division of Biometrics, HFD-710,

Ting Eng Ong Division of Biopharmaceutics HFD-423, Center for Drug Evaluation and Research U.S. Food and Drug Administration, 5600 Fishers Lane, Rockville, Maryland, 20857

Citations (12)

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Steven Novick, Yan Shen, Harry Yang, John Peterson, Dave LeBlond & Stan Altan. (2015) Dissolution Curve Comparisons Through the F2 Parameter, a Bayesian Extension of the f2 Statistic. Journal of Biopharmaceutical Statistics 25:2, pages 351-371.
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Yi Tsong, Meiyu Shen & Vinod P. Shah. (2004) Three-Stage Sequential Statistical Dissolution Testing Rules. Journal of Biopharmaceutical Statistics 14:3, pages 757-779.
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Shein-Chung Chow & Jun Shao. (2002) ON THE ASSESSMENT OF SIMILARITY FOR DISSOLUTION PROFILES OF TWO DRUG PRODUCTS. Journal of Biopharmaceutical Statistics 12:3, pages 311-321.
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Shein-Chung Chow, Jun Shao & Hansheng Wang. (2002) Probability lower bounds for USP/NF tests. Journal of Biopharmaceutical Statistics 12:1, pages 79-92.
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Ralph A. DeMasi, Dana Quade & Chuan-Feng Shih. (1998) Statistical methodology for screening studies with qualitative/quantitative mixtures. Journal of Biopharmaceutical Statistics 8:1, pages 69-85.
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Yi Tsong, Thomas Hammerstrom & James J. Chen. (1997) Multipoint dissolution specification and acceptance sampling rule based on profile modeling and principal component analysis. Journal of Biopharmaceutical Statistics 7:3, pages 423-439.
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Articles from other publishers (6)

Gulam Mustafa, Md Ali Mujtaba, Sabna Kotta, Abdullah Habeeballah, Nabil A. Alhakamy, Hibah M. Aldawsari, Shahid Karim & Shadab Md. 2022. Regulatory Affairs in the Pharmaceutical Industry. Regulatory Affairs in the Pharmaceutical Industry 215 240 .

Mohammad M Islam. (2018) Bootstrap confidence intervals for dissolution similarity factor f2. Biometrics & Biostatistics International Journal 7:5.
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Rubén M. Maggio, Patricia M. Castellano & Teodoro S. Kaufman. (2008) A new principal component analysis-based approach for testing “similarity” of drug dissolution profiles. European Journal of Pharmaceutical Sciences 34:1, pages 66-77.
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Monica L. Dumont, Mark R. Berry & Beverly Nickerson. (2007) Probability of passing dissolution acceptance criteria for an immediate release tablet. Journal of Pharmaceutical and Biomedical Analysis 44:1, pages 79-84.
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Walter W. Hauck, Thomas Foster, Eric Sheinin, Todd Cecil, William Brown, Margareth Marques & Roger L. Williams. (2005) Oral Dosage Form Performance Tests: New Dissolution Approaches. Pharmaceutical Research 22:2, pages 182-187.
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Shein-Chung Chow & Jen-Pei Liu. (2016) Current Issues in Bioequivalence Trials. Drug Information Journal 29:3, pages 795-804.
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Dissolution test acceptance sampling plansFootnote^∗
^∗The views expressed in this paper are the authors' professional opinions. They do not represent the official of the U.S. Food and Drug Administration.

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Dissolution test acceptance sampling plansFootnote∗∗The views expressed in this paper are the authors' professional opinions. They do not represent the official of the U.S. Food and Drug Administration.

Citations (12)

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Articles from other publishers (6)

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Academic Permissions

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Dissolution test acceptance sampling plansFootnote^∗
^∗The views expressed in this paper are the authors' professional opinions. They do not represent the official of the U.S. Food and Drug Administration.