1. Role of Model‐Informed Drug Development in Pediatric Drug Development, Regulatory Evaluation, and Labeling. (10th September 2019) Authors: Bi, Youwei; Liu, Jiang; Li, Lingjue; Yu, Jingyu; Bhattaram, Atul; Bewernitz, Michael; Li, Ruo‐jing; Liu, Chao; Earp, Justin; Ma, Lian; Zhuang, Luning; Yang, Yuching; Zhang, Xinyuan; Zhu, Hao; Wang, Yaning Other Names: Burckart Gilbert J. guestEditor.; van den Anker John N. guestEditor. Journal: Journal of clinical pharmacology Issue: Volume 59(2019)Supplement 1 Page Start: S104 Record Type: Journal Article View Content: Available online (eLD content is only available in our Reading Rooms) ↗
2. Consideration of a Credibility Assessment Framework in Model‐Informed Drug Development: Potential Application to Physiologically‐Based Pharmacokinetic Modeling and Simulation. (10th November 2019) Authors: Kuemmel, Colleen; Yang, Yuching; Zhang, Xinyuan; Florian, Jeffry; Zhu, Hao; Tegenge, Million; Huang, Shiew‐Mei; Wang, Yaning; Morrison, Tina; Zineh, Issam Journal: CPT: pharmacometrics & systems pharmacology Issue: Volume 9:Number 1(2020) Page Start: 21 Record Type: Journal Article View Content: Available online (eLD content is only available in our Reading Rooms) ↗
3. Development of best practices in physiologically based pharmacokinetic modeling to support clinical pharmacology regulatory decision‐making—A workshop summary. (18th September 2021) Authors: 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; W... Journal: CPT: pharmacometrics & systems pharmacology Issue: Volume 10:Number 11(2021) Page Start: 1271 Record Type: Journal Article View Content: Available online (eLD content is only available in our Reading Rooms) ↗
4. Model‐Informed Drug Development Approaches to Assist New Drug Development in the COVID‐19 Pandemic. Issue 3 (4th December 2021) Authors: Xiong, Ye; Fan, Jianghong; Kitabi, Eliford; Zhang, Xinyuan; Bi, Youwei; Grimstein, Manuela; Yang, Yuching; Earp, Justin C.; Zheng, Nan; Liu, Jiang; Wang, Yaning; Zhu, Hao Journal: Clinical pharmacology & therapeutics Issue: Volume 111:Issue 3(2022) Page Start: 572 Record Type: Journal Article View Content: Available online (eLD content is only available in our Reading Rooms) ↗
5. Whole Body PBPK Modeling of Remdesivir and Its Metabolites to Aid in Estimating Active Metabolite Exposure in the Lung and Liver in Patients With Organ Dysfunction. Issue 3 (8th November 2021) Authors: Fan, Jianghong; Yang, Yuching; Grimstein, Manuela; Zhang, Xinyuan; Kitabi, Eliford; Earp, Justin C; Arya, Vikram; Reynolds, Kellie S; Zhu, Hao; Wang, Yaning Journal: Clinical pharmacology & therapeutics Issue: Volume 111:Issue 3(2022) Page Start: 624 Record Type: Journal Article View Content: Available online (eLD content is only available in our Reading Rooms) ↗
6. Anti–SARS‐CoV‐2 Repurposing Drug Database: Clinical Pharmacology Considerations. (1st August 2021) Authors: 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 Journal: CPT: pharmacometrics & systems pharmacology Issue: Volume 10:Number 9(2021) Page Start: 973 Record Type: Journal Article View Content: Available online (eLD content is only available in our Reading Rooms) ↗
7. FDA Approval Summary: Midostaurin for the Treatment of Advanced Systemic Mastocytosis. (16th August 2018) Authors: 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 Journal: Oncologist Issue: Volume 23:Number 12(2018) Page Start: 1511 Record Type: Journal Article View Content: Available online (eLD content is only available in our Reading Rooms) ↗
8. Human radiolabeled mass balance studies supporting the FDA approval of new drugs. Issue 11 (23rd September 2022) Authors: 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 Journal: Clinical and translational science Issue: Volume 15:Issue 11(2022) Page Start: 2567 Record Type: Journal Article View Content: Available online (eLD content is only available in our Reading Rooms) ↗
9. Model‐Informed Drug Development in Pediatric Dose Selection. (29th June 2021) Authors: Bi, Youwei; Liu, Jiang; Li, Fang; Yu, Jingyu; Bhattaram, Atul; Bewernitz, Michael; Li, Ruo‐jing; Ahn, Jihye; Earp, Justin; Ma, Lian; Zhuang, Luning; Yang, Yuching; Zhang, Xinyuan; Zhu, Hao; Wang, Yaning Other Names: Burckart Gilbert J. guestEditor.; van den Anker John N. guestEditor. Journal: Journal of clinical pharmacology Issue: Volume 61(2021)Supplement 1 Page Start: S60 Record Type: Journal Article View Content: Available online (eLD content is only available in our Reading Rooms) ↗
10. Connecting Hydroxychloroquine In Vitro Antiviral Activity to In Vivo Concentration for Prediction of Antiviral Effect: A Critical Step in Treating Patients With Coronavirus Disease 2019. (21st May 2020) Authors: Fan, Jianghong; Zhang, Xinyuan; Liu, Jiang; Yang, Yuching; Zheng, Nan; Liu, Qi; Bergman, Kimberly; Reynolds, Kellie; Huang, Shiew-Mei; Zhu, Hao; Wang, Yaning Journal: Clinical infectious diseases Issue: Volume 71:Number 12(2020) Page Start: 3232 Record Type: Journal Article View Content: Available online (eLD content is only available in our Reading Rooms) ↗