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Acute Exacerbation and Decline in Forced Vital Capacity Are Associated with Increased Mortality in Idiopathic Pulmonary Fibrosis.
Published in:
2017
By:
- Paterniti, Miya O.;
- Youwei Bi;
- Rekić, Dinko;
- Yaning Wang;
- Karimi-Shah, Banu A.;
- Chowdhury, Badrul A.;
- Bi, Youwei;
- Wang, Yaning
Publication type:
journal article
Experience Learned and Perspectives on Using Model-Integrated Evidence in the Regulatory Context for Generic Drug Products—a Meeting Report.
Published in:
AAPS Journal, 2024, v. 26, n. 1, p. 1, doi. 10.1208/s12248-023-00884-5
By:
- Tsakalozou, Eleftheria;
- Fang, Lanyan;
- Bi, Youwei;
- van den Heuvel, Michiel;
- Ahmed, Tausif;
- Tsang, Yu Chung;
- Lionberger, Robert;
- Rostami-Hodjegan, Amin;
- Zhao, Liang
Publication type:
Article
Model-Informed Drug Development Approach Supporting Approval of Adalimumab (HUMIRA) in Adolescent Patients with Hidradenitis Suppurativa: a Regulatory Perspective.
Published in:
AAPS Journal, 2019, v. 21, n. 5, p. N.PAG, doi. 10.1208/s12248-019-0363-5
By:
- Bi, Youwei;
- Liu, Jiang;
- Wang, Jie;
- Epps, Roselyn E.;
- Kettl, David;
- Marcus, Kendall;
- Seo, Shirley;
- Zhu, Hao;
- Wang, Yaning
Publication type:
Article
A Whole-Body Physiologically Based Pharmacokinetic Model of Gefitinib in Mice and Scale-Up to Humans.
Published in:
AAPS Journal, 2016, v. 18, n. 1, p. 228, doi. 10.1208/s12248-015-9836-3
By:
- Bi, Youwei;
- Deng, Jiexin;
- Murry, Daryl;
- An, Guohua
Publication type:
Article
Approval of Mycophenolate Mofetil for Prophylaxis of Organ Rejection in Pediatric Recipients of Heart or Liver Transplants: A Regulatory Perspective.
Published in:
Clinical Pharmacology & Therapeutics, 2024, v. 116, n. 3, p. 807, doi. 10.1002/cpt.3288
By:
- Al‐Khouja, Amer;
- Chaudhri, Nadia;
- Velidedeoglu, Ergun;
- Belen, Ozlem;
- Bi, Youwei;
- Doddapaneni, Suresh;
- Chen, Jianmeng
Publication type:
Article
Model‐Informed Drug Development Approaches to Assist New Drug Development in the COVID‐19 Pandemic.
Published in:
Clinical Pharmacology & Therapeutics, 2022, v. 111, n. 3, p. 572, doi. 10.1002/cpt.2491
By:
- 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
Publication type:
Article
Population Pharmacokinetic/Pharmacodynamic Modeling of Depot Testosterone Cypionate in Healthy Male Subjects.
Published in:
CPT: Pharmacometrics & Systems Pharmacology, 2018, v. 7, n. 4, p. 259, doi. 10.1002/psp4.12287
By:
- Bi, Youwei;
- Perry, Paul J.;
- Ellerby, Michael;
- Murry, Daryl J.
Publication type:
Article
A disease progression model of longitudinal lung function decline in idiopathic pulmonary fibrosis patients.
Published in:
Journal of Pharmacokinetics & Pharmacodynamics, 2021, v. 48, n. 1, p. 55, doi. 10.1007/s10928-020-09718-9
By:
- Bi, Youwei;
- Rekić, Dinko;
- Paterniti, Miya O.;
- Chen, Jianmeng;
- Marathe, Anshu;
- Chowdhury, Badrul A.;
- Karimi-Shah, Banu A.;
- Wang, Yaning
Publication type:
Article
Model‐Informed Approaches to Support Drug Development for Patients With Obesity: A Regulatory Perspective.
Published in:
Journal of Clinical Pharmacology, 2023, v. 63, p. S65, doi. 10.1002/jcph.2349
By:
- Pan, Xiaolei;
- Wang, Li;
- Liu, Jiang;
- Earp, Justin C.;
- Yang, Yuching;
- Yu, Jingyu;
- Li, Fang;
- Bi, Youwei;
- Bhattaram, Atul;
- Zhu, Hao
Publication type:
Article
Model‐Informed Approach Supporting Drug Development and Regulatory Evaluation for Rare Diseases.
Published in:
Journal of Clinical Pharmacology, 2022, v. 62, p. S27, doi. 10.1002/jcph.2143
By:
- Li, Ruo‐Jing;
- Ma, Lian;
- Li, Fang;
- Li, Liang;
- Bi, Youwei;
- Yuan, Ye;
- Li, Yangbing;
- Xu, Yuan;
- Zhang, Xinyuan;
- Liu, Jiang;
- Bhattaram, Venkatesh Atul;
- Wang, Jie;
- Schuck, Robert;
- Pacanowski, Michael;
- Zhu, Hao
Publication type:
Article
Model‐Informed Drug Development in Pediatric Dose Selection.
Published in:
Journal of Clinical Pharmacology, 2021, v. 61, p. S60, doi. 10.1002/jcph.1848
By:
- 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
Publication type:
Article
Role of Model‐Informed Drug Development in Pediatric Drug Development, Regulatory Evaluation, and Labeling.
Published in:
Journal of Clinical Pharmacology, 2019, v. 59, p. S104, doi. 10.1002/jcph.1478
By:
- 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
Publication type:
Article
Role of Model‐Informed Drug Development in Pediatric Drug Development, Regulatory Evaluation, and Labeling.
Published in:
Journal of Clinical Pharmacology, 2019, v. 59, p. S104, doi. 10.1002/jcph.1478
By:
- 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
Publication type:
Article
Benefit‐Risk Summary of Regorafenib for the Treatment of Patients with Advanced Hepatocellular Carcinoma That Has Progressed on Sorafenib.
Published in:
Oncologist, 2018, v. 23, n. 4, p. 496, doi. 10.1634/theoncologist.2017-0422
By:
- Pelosof, Lorraine;
- Lemery, Steven;
- Casak, Sandra;
- Jiang, Xiaoping;
- Rodriguez, Lisa;
- Pierre, Vadryn;
- Bi, Youwei;
- Liu, Jiang;
- Zirkelbach, Jeanne Fourie;
- Patel, Anuja;
- Goldberg, Kirsten B.;
- McKee, Amy E.;
- Keegan, Patricia;
- Pazdur, Richard
Publication type:
Article

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