Consideration of a Credibility Assessment Framework in Model‐Informed Drug Development: Potential Application to Physiologically‐Based Pharmacokinetic Modeling and Simulation

por Kuemmel, Colleen, Yang, Yuching, Zhang, Xinyuan, Florian, Jeffry, Zhu, Hao, Tegenge, Million, Huang, Shiew‐Mei, Wang, Yaning, Morrison, Tina, Zineh, Issam
Publicado 2019

Regulatory utility of physiologically based pharmacokinetic modeling for assessing food impact in bioequivalence studies: A workshop summary report

por Al Shoyaib, Abdullah, Riedmaier, Arian Emami, Kumar, Anita, Roy, Partha, Parrott, Neil John, Fang, Lanyan, Tampal, Nilufer, Yang, Yuching, Jereb, Rebeka, Zhao, Liang, Wu, Fang
Publicado 2023

FDA Approval Summary: Midostaurin for the Treatment of Advanced Systemic Mastocytosis

por Kasamon, Yvette L., Ko, Chia‐Wen, Subramaniam, Sriram, Ma, Lian, Yang, Yuching, Nie, Lei, Shord, Stacy, Przepiorka, Donna, Farrell, Ann T., McKee, Amy E., Pazdur, Richard
Publicado 2018

Human radiolabeled mass balance studies supporting the FDA approval of new drugs

por Ramamoorthy, Anuradha, Bende, Girish, Chow, Edwin Chiu Yuen, Dimova, Hristina, Hartman, Neil, Jean, Daphney, Pahwa, Sonia, Ren, Yunzhao, Shukla, Chinmay, Yang, Yuching, Doddapaneni, Suresh, Danielsen, Zhixia Yan
Publicado 2022

Differing Relations to Early Atherosclerosis between Vitamin C from Supplements vs. Food in the Los Angeles Atherosclerosis Study: A Prospective Cohort Study

por Agarwal, Megha, Mehta, Puja K, Dwyer, James H, Dwyer, Kathleen M, Shircore, Anne M, Nordstrom, Cheryl K, Sun, Ping, Paul-Labrador, Maura, Yang, Yuching, Merz, C. Noel Bairey
Publicado 2012

Modeling Drug- and Chemical-Induced Hepatotoxicity with Systems Biology Approaches

por Bhattacharya, Sudin, Shoda, Lisl K.M., Zhang, Qiang, Woods, Courtney G., Howell, Brett A., Siler, Scott Q., Woodhead, Jeffrey L., Yang, Yuching, McMullen, Patrick, Watkins, Paul B., Andersen, Melvin E.
Publicado 2012

Anti–SARS‐CoV‐2 Repurposing Drug Database: Clinical Pharmacology Considerations

por Zhang, Xinyuan, Yang, Yuching, Grimstein, Manuela, Liu, Guansheng, Kitabi, Eliford, Fan, Jianghong, Wang, Ying‐Hong, Earp, Justin, Weaver, James L., Zhu, Hao, Liu, Jiang, Reynolds, Kellie S., Huang, Shiew‐Mei, Wang, Yaning
Publicado 2021

Quantitative systems toxicology (QST) reproduces species differences in PF‐04895162 liver safety due to combined mitochondrial and bile acid toxicity

por Generaux, Grant, Lakhani, Vinal V., Yang, Yuching, Nadanaciva, Sashi, Qiu, Luping, Riccardi, Keith, Di, Li, Howell, Brett A., Siler, Scott Q., Watkins, Paul B., Barton, Hugh A., Aleo, Michael D., Shoda, Lisl K. M.
Publicado 2019

Development of best practices in physiologically based pharmacokinetic modeling to support clinical pharmacology regulatory decision‐making—A workshop summary

por Jean, Daphney, Naik, Kunal, Milligan, Lauren, Hall, Stephen, Mei Huang, Shiew, Isoherranen, Nina, Kuemmel, Colleen, Seo, Paul, Tegenge, Million A., Wang, Yaning, Yang, Yuching, Zhang, Xinyuan, Zhao, Liang, Zhao, Ping, Benjamin, Jessica, Bergman, Kimberly, Grillo, Joseph, Madabushi, Rajanikanth, Wu, Fang, Zhu, Hao, Zineh, Issam
Publicado 2021