arrow
返回
M

Meng Hu

us food & drug administration (fda)

15H指数
50论文数
660被引数
收录论文 27
发表时间
Bioequivalence of ANDA Data using a Non-Informative Bayesian Procedure (BEST) Compared with the Two One-Sided t-Tests (TOST)
err2025-02-19
err0
PREAI
errWang, Jing; Campbell, Gregory; Lee, Jae H.; Hu, Meng; Feng, Kairui; Chattopadhyay, Somesh; Zhao, Liang; Peck, Carl C.
err分享
err收藏
Application of Advanced Modeling Approaches Supporting Generic Product Development Under GDUFA for Fiscal Year 2023
err2024-04-24
err0
errOAAI
errTsakalozou, Eleftheria; Gong, Yuqing; Babiskin, Andrew; Hu, Meng; Mousa, Youssef; Walenga, Ross; Wu, Fang; Yoon, Miyoung; Raney, Sam G.; Polli, James E.; Schwendeman, Anna; Krishnan, Vishalakshi; Fang, Lanyan; Zhao, Liang
err分享
err收藏
Development of Quantitative Comparative Approaches to Support Complex Generic Drug Development
err2024-01-24
err1
PREAI
errGong, Yuqing; Barretto, Francis-Xavier; Tsong, Yi; Mousa, Youssef; Ren, Ke; Kozak, Darby; Shen, Meiyu; Hu, Meng; Zhao, Liang
err分享
err收藏
pyDarwin : A Machine Learning Enhanced Automated Nonlinear Mixed-Effect Model Selection Toolbox
err2024-01-10
err5
errOAAI
errLi, Xinnong; Sale, Mark; Nieforth, Keith; Bigos, Kristin L.; Craig, James; Wang, Fenggong; Feng, Kairui; Hu, Meng; Bies, Robert; Zhao, Liang
err分享
err收藏
err分享
err收藏
PharmBERT: a domain-specific BERT model for drug labels
err2023-06-14
err12
PREAI
errValizadehAslani, Taha; Shi, Yiwen; Ren, Ping; Wang, Jing; Zhang, Yi; Hu, Meng; Zhao, Liang; Liang, Hualou
err分享
err收藏
err分享
err收藏
Fine-tuning BERT for automatic ADME semantic labeling in FDA drug labeling to enhance product-specific guidance assessment
err2023-02-01
err11
errOAAI
errShi, Yiwen; Wang, Jing; Ren, Ping; ValizadehAslani, Taha; Zhang, Yi; Hu, Meng; Liang, Hualou
err分享
err收藏
Product Quality Research for Developing and Assessing Regulatory Submissions for Generic Cyclosporine Ophthalmic Emulsions
err2023-01-26
err0
errOAAI
errBelenos, Avery; Wood, Erin Leigh; Hu, Meng; Kozak, Darby; Xu, Xiaoming; Fisher, Adam C.
err分享
err收藏
Comparing a Bayesian Approach (BEST) with the Two One-Sided t-Tests (TOSTs) for Bioequivalence Studies
err2022-09-01
err2
errOAAI
errPeck, Carl; Campbell, Gregory; Yoo, Isaac; Feng, Kairui; Hu, Meng; Zhao, Liang
err分享
err收藏
Decoding kinase-adverse event associations for small molecule kinase inhibitors
err2022-07-27
err8
errOAAI
errGong, Xiajing; Hu, Meng; Liu, Jinzhong; Kim, Geoffrey; Xu, James; McKee, Amy; Palmby, Todd; de Claro, R. Angelo; Zhao, Liang
err分享
err收藏
err分享
err收藏
Virtual screening FDA approved drugs against multiple targets of SARS-CoV-2
err2021-05-02
err15
errOAAI
errLiang, Hualou; Zhao, Liang; Gong, Xiajing; Hu, Meng; Wang, Hongbin
err分享
err收藏
Equivalence Testing of Complex Particle Size Distribution Profiles Based on Earth Mover's Distance (vol 20, 62, 2018)
err2020-08-14
err0
errOAAI
errHu, Meng; Jiang, Xiaohui; Absar, Mohammad; Choi, Stephanie; Kozak, Darby; Shen, Meiyu; Weng, Yu-Ting; Zhao, Liang; Lionberger, Robert
err分享
err收藏
Predictive Analysis of First Abbreviated New Drug Application Submission for New Chemical Entities Based on Machine Learning Methodology
err2019-06-12
err9
PREAI
errHu, Meng; Babiskin, Andrew; Wittayanukorn, Saranrat; Schick, Andreas; Rosenberg, Matthew; Gong, Xiajing; Kim, Myong-Jin; Zhang, Lei; Lionberger, Robert; Zhao, Liang
err分享
err收藏
WHAT FACTORS MAY IMPACT THE LIKELIHOOD OF FIRST ABBREVIATED NEW DRUG APPLICATION (ANDA) SUBMISSION FOR A REFERENCE PRODUCT?
err2018-05-01
err1
errOAAI
errWittayanukorn, S.; Rosenberg, M.; Schick, A.; Hu, M.; Wang, Z.; Babiskin, A.; Zhao, L.
err分享
err收藏