Full Text Journal Articles by Author Richard T Lostritto (Page 1)
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Yi Tsong, Xiaoyu Dong, Meiyu Shen, Richard T Lostritto,. The delivered dose uniformity is one of the most critical requirements for dry powder inhaler (DPI) ... › search › Author-Richar...
Statistical Properties of Large Sample Tests for Dose Content ...
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2014 · Cited by 7 — Meiyu Shen, PhD1, Yi Tsong, PhD1, and Xiaoyu Dong, PhD1. Abstract. The European Union (EU) test for uniformity of dosage units using large sample sizes was ... › viewdoc › download
Mesalamine-Statistical-PREA.pdf - FDA.report
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Mar 31, — Meiyu Shen, Ph.D., Team Leader, Mathematical Statistician, CDER/OTS/OB/DB VI. Concur: Yi Tsong, Ph.D., Division Director, DBVI, ... › media › Mesalamine-S...
Orig1s Food and Drug Administration
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Meiyu Shen, PhD, Lead Mathematical Statistician Concur: _____ Yi Tsong, Ph.D., Division Director, DBVI Distribution: CDER/OTS/OB/DB VI/Yi Tsong CDER/OTS/OB/Lillian Patrician CDER/OBP/Kurt Brorson CDER/OBP/Cyrus Agarabi CDER/TBBS 1 This reflects information for Inflectra that Celltrion submitted on August 8, We note that the indication for pediatric ...
Regulatory Nonclinical Statistics - Semantic Scholar
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Mohammad Atiar Rahman, Meiyu Shen, Xiaoyu (Cassie) Dong, Karl K. Lin, and Yi Tsong. Abstract The nonclinical statistics teams in the Center of Drug Review and. Research of the Food and Drug Administration (FDA) conduct regulatory reviews, statistical consultation, and statistical methodology development in ...
Development of statistical methods for analytical similarity ...
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by Y Tsong · · Cited by 44 — Authors. Yi Tsong , Xiaoyu Dong , Meiyu Shen. Affiliations. 1 a Office of Biostatistics, Office of Translational Science, CDER, FDA , Silver Spring ... by Y Tsong · · Cited by 8 — Authors. Yi Tsong , Meiyu Shen. Affiliation. 1 Division of Biometric VI, OB, CDER, FDA, Silver Spring, MD , USA. .gov. › ...
Statistical evaluation of several methods for cut-point ...
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Meiyu Shen 1 , Xiaoyu Dong, Yi Tsong. Affiliation 1 a Office of Biostatistics , /Office of Translational Sciences, Center for Drug Evaluation and Research, U.S. Food and Drug Administration , Silver Spring , Maryland , USA. PMID: DOI:
All web results to the name "Meiyu Shen"
PPT - Drs. Yi Tsong 1 , Xiaoyu (Cassie) Dong* 1 , Meiyu Shen ...
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(PDF) Statistical evaluation of several methods for cut-point ...
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Click for updates To cite this article: Meiyu Shen, Xiaoyu Dong & Yi Tsong ... DETERMINATION OF IMMUNOGENICITY SCREENING ASSAY Meiyu Shen, Xiaoyu Dong, ... › Statistical_evaluation_of_se...
(PDF) Statistical evaluation of several methods for cut ...
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Meiyu Shen. Yi Tsong. Xiaoyu Dong. Download PDF. Download Full PDF Package. This paper. A short summary of this paper. 33 Full PDFs related to this paper. Read Paper. Statistical evaluation of several methods for cut-point determination of immunogenicity screening assay. Download. Related Papers. A modified area under the ROC curve and its application to marker selection …
Archive - ClinMed International Library
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Yu-Ting Weng, Yi Tsong, Meiyu Shen and Chao Wang. Article Type: Research Article | First Published: March 15, The equivalence test in analytical ... › archives_search
Statistical considerations in setting product specifications.
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Xiaoyu Dong , Yi Tsong & Meiyu Shen a. Division of Biometrics VI, Office of Biostatistics, Office of Translational Sciences, Center for Drug Evaluation and ... › ...
Meiyu Shen, PhD Collaborators: Xiaoyu Dong, Ph.D., Yi Tsong, PhD -...
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1 Large sample dose content uniformity test: parametric and nonparametric (counting) Meiyu Shen, PhD Collaborators: Xiaoyu Dong, Ph.D., Yi Tsong, PhD Office of Biostatistics, CDER, FDA * This presentation contains opinions of the authors that do not represent the official position of U.S. Food and Drug Administration.
Statistical and Data Management Approaches for Biotechnology Drug...
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Meiyu Shen FDA Andrew Rugaiganisa Pfizer Yi Tsong FDA Fei Wang Genzyme Harry Yang Medimmune Lanju Zhang AbbVie Meeting management: IABS Geneva, …
Statistical Evaluation of Several Methods for Cut-Point Determination...
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Statistical Evaluation of Several Methods for Cut-Point Determination of Immunogenicity Screening Assay. Meiyu Shen, Xiaoyu Dong, Yi Tsong. Journal of ...
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