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

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