Paper Review Records
All Paper Review Records
10 valid samples · Newest publication first
Review days = acceptance date − received date. PDF, DOI, and publisher-page sources are retained.
Special issue of nonclinical statistics in regulatory applications guest editors’ notes
AuthorsMeiyu Shen; Victoria Chang; Yi Tsong
Affiliations1. US Food and Drug Administration; 2. BeOne Medicines
Comparison of in-vitro release rates for vaginal systems
AuthorsMeiyu Shen; Xiaoyu Cai; Vidula Kolhatkar
Affiliations1. Division of Biometrics VI, Office of Biostatistics, Office of Translational Sciences, Center for Drug Evaluation and Research, Food and Drug Administration; 2. Division of Biopharmaceutics, Office of New Drug Products, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, Food and Drug Administration
Statistical approaches for shelf-life determination of a drug product
AuthorsTengfei Li; Xutong Zhao; Meiyu Shen; Yi Tsong
Affiliations1. U.S. Food and Drug Administration
Tolerance and prediction intervals: The Bayesian way
AuthorsJosé G. Ramírez; Fang Chen
Affiliations1. A Gilead Company, Santa Monica, CA, USA; 2. SAS Institute Inc., Cary, NC, USA
Parallelism of four-parameter logistic bioassay models: equivalence testing for parameter differences*
AuthorsJi Li; Chang Chen; Meiyu Shen; Yi Tsong
Affiliations1. University of Maryland; 2. U.S. Food and Drug Administration, Silver Spring, MD, USA
A survey of parallelism testing methods for bioassays
AuthorsChao Wang; Ji Li; Chang Chen; Meiyu Shen; Chunrong Cheng; Yi Tsong
Affiliations1. U.S. Food and Drug Administration; 2. University of Maryland at Baltimore County
An exploratory application of modern statistical methodology and machine learning techniques in assessment of crystallinity monitoring and control strategy development for high-risk drug manufacturing
AuthorsKevin L. Chen; Yingjie Chen; Huiquan Wu
Affiliations1. Office of Pharmaceutical Manufacturing Assessment (OPMA), OPQ, CDER, US Food and Drug Administration (FDA), Silver Spring, USA
Statistical approaches to classify investigational product using hERG safety assay
AuthorsYu-Ting Weng; Dalong Huang
Affiliations1. Office of Biostatistics, Office of Translational Sciences, CDER, FDA, Silver Spring, Maryland, USA
A multivariate equivalence test based on Mahalanobis distance with a data-driven margin
AuthorsChao Wang; Yu-Ting Weng; Shaobo Liu; Tengfei Li; Meiyu Shen; Yi Tsong
Affiliations1. U.S. Food and Dru Administration
Advances in statistical methodologies for assessing bioequivalence of topical dermatological products
AuthorsElena Rantou; Namhee Choi; Sungwoo Choi; Jessica Kim; Stella Grosser
Affiliations1. U.S. Food and Drug Administration
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