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Review Cycle Records

Journal of Biopharmaceutical Statistics

Taylor & Francis SCIE Non-OA
2026 Emerging Zone 42025 CAS Zone 42025 JCR Q2
53.6Average days
56Median days
1Fastest days
100Longest days
932025 publications

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.

1 days

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

Source PDF DOI Publisher page
42 days

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

Source PDF DOI Publisher page
45 days

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

Source PDF DOI Publisher page
67 days

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

Source PDF DOI Publisher page
96 days

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

Source PDF DOI Publisher page
8 days

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

Source PDF DOI Publisher page
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

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

Source PDF DOI Publisher page
38 days

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

Source PDF DOI Publisher page
100 days

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

Source PDF DOI Publisher page
67 days

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

Source PDF DOI Publisher page

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Machine Learning and Life-Cycle Assessment for Predicting and Optimizing Carbon Emissions in Urban Wastewater Treatment

SampleLatest 5 valid paper samples from 2026

Average review96.4 days

Median77 days

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