FDA Approval Summary: Fam-Trastuzumab Deruxtecan-Nxki for the Treatment of Unresectable or Metastatic HER2-Positive Breast Cancer von Narayan, Preeti, Osgood, Christy L, Singh, Harpreet, Chiu, Haw-Jyh, Ricks, Tiffany K, Chiu Yuen Chow, Edwin, Qiu, Junshan, Song, Pengfei, Yu, Jingyu, Namuswe, Frances, Guiterrez-Lugo, Maria, Hou, Sherry, Pierce, William F, Goldberg, Kirsten B, Tang, Shenghui, Amiri-Kordestani, Laleh, Theoret, Marc R, Pazdur, Richard, Beaver, Julia A

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

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Comparability Considerations and Challenges for Expedited Development Programs for Biological Products von Schrieber, Sarah J., Putnam, Wendy S., Chow, Edwin Chiu Yuen, Cieslak, Jacek, Zhuang, Yanli, Martin, Steven W., Hanson, Paul, Maggio, Frank, Rosado, Leslie A. Rivera

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FDA Approval Summary: Ivosidenib for the Treatment of Patients with Advanced Unresectable or Metastatic, Chemotherapy Refractory Cholangiocarcinoma with an IDH1 Mutation von Casak, Sandra J, Pradhan, Shan, Fashoyin-Aje, Lola A, Ren, Yi, Shen, Yuan-Li, Xu, Yuan, Chow, Edwin Chiu Yuen, Xiong, Ye, Zirklelbach, Jeanne Fourie, Liu, Jiang, Charlab, Rosane, Pierce, William F, Fesenko, Nataliya, Beaver, Julia A, Pazdur, Richard, Kluetz, Paul G, Lemery, Steven J

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Using Physiologically Based Pharmacokinetic (PBPK) Modeling to Evaluate the Impact of Pharmaceutical Excipients on Oral Drug Absorption: Sensitivity Analyses von Chow, Edwin Chiu Yuen, Talattof, Arjang, Tsakalozou, Eleftheria, Fan, Jianghong, Zhao, Liang, Zhang, Xinyuan

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