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.
72
days
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
Authors
Kevin L. Chen; Yingjie Chen; Huiquan WuShow moreShow less
Affiliations
1. Office of Pharmaceutical Manufacturing Assessment (OPMA), OPQ, CDER, US Food and Drug Administration (FDA), Silver Spring, USAShow moreShow less
38
days
Statistical approaches to classify investigational product using hERG safety assay
Authors
Yu-Ting Weng; Dalong HuangShow moreShow less
Affiliations
1. Office of Biostatistics, Office of Translational Sciences, CDER, FDA, Silver Spring, Maryland, USAShow moreShow less
100
days
A multivariate equivalence test based on Mahalanobis distance with a data-driven margin
Authors
Chao Wang; Yu-Ting Weng; Shaobo Liu; Tengfei Li; Meiyu Shen; Yi TsongShow moreShow less
Affiliations
1. U.S. Food and Dru AdministrationShow moreShow less
67
days
Advances in statistical methodologies for assessing bioequivalence of topical dermatological products
Authors
Elena Rantou; Namhee Choi; Sungwoo Choi; Jessica Kim; Stella GrosserShow moreShow less
Affiliations
1. U.S. Food and Drug AdministrationShow moreShow less
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