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Modeling effects of dexamethasone on disease progression of bone mineral density in collagen-induced arthritic rats.
Published in:
Pharmacology Research & Perspectives, 2015, v. 3, n. 5, p. 1, doi. 10.1002/prp2.169
By:
- Lon, Hoi ‐ Kei;
- DuBois, Debra C.;
- Earp, Justin C.;
- Almon, Richard R.;
- Jusko, William J.
Publication type:
Article
Utility of islet autoantibodies as enrichment biomarkers in type 1 diabetes clinical studies: a viewpoint from the FDA.
Published in:
2023
By:
- Penzenstadler, Justin;
- Earp, Justin C.;
- Wood Heickman, Lauren K.;
- Pluchino, Kristen
Publication type:
Letter
FDA-Industry Scientific Exchange on assessing quantitative systems pharmacology models in clinical drug development: a meeting report, summary of challenges/gaps, and future perspective.
Published in:
AAPS Journal, 2021, v. 23, n. 3, p. 1, doi. 10.1208/s12248-021-00585-x
By:
- Bai, Jane P. F.;
- Schmidt, Brian J.;
- Gadkar, Kapil G.;
- Damian, Valeriu;
- Earp, Justin C.;
- Friedrich, Christina;
- van der Graaf, Piet H.;
- Madabushi, Rajanikanth;
- Musante, Cynthia J.;
- Naik, Kunal;
- Rogge, Mark;
- Zhu, Hao
Publication type:
Article
Translational Quantitative Systems Pharmacology in Drug Development: from Current Landscape to Good Practices.
Published in:
AAPS Journal, 2019, v. 21, n. 4, p. N.PAG, doi. 10.1208/s12248-019-0339-5
By:
- Bai, Jane P. F.;
- Earp, Justin C.;
- Pillai, Venkateswaran C.
Publication type:
Article
Therapeutic Protein Drug-Drug Interactions: Navigating the Knowledge Gaps-Highlights from the 2012 AAPS NBC Roundtable and IQ Consortium/FDA Workshop.
Published in:
2013
By:
- Kenny, Jane;
- Liu, Maggie;
- Chow, Andrew;
- Earp, Justin;
- Evers, Raymond;
- Slatter, J.;
- Wang, Diane;
- Zhang, Lei;
- Zhou, Honghui
Publication type:
Report
Targeting 11q23 positive acute leukemia cells with high molecular weight-melanoma associated antigen-specific monoclonal antibodies.
Published in:
Cancer Immunology, Immunotherapy, 2009, v. 58, n. 3, p. 415, doi. 10.1007/s00262-008-0567-5
By:
- Drake, Allison S.;
- Brady, Michael T.;
- Xin Hui Wang;
- Sait, Sheila J. N.;
- Earp, Justin C.;
- Ghoshal (Gupta), Sampa;
- Ferrone, Soldano;
- Wang, Eunice S.;
- Wetzler, Meir
Publication type:
Article
Reply to White et al.
Published in:
2022
By:
- Kitabi, Eliford;
- Bensman, Timothy J;
- Earp, Justin C;
- Chilukuri, Dakshina M;
- Smith, Heidi;
- Ball, Leslie;
- O'Shaughnessy, Elizabeth;
- Yasinskaya, Yuliya;
- Reynolds, Kellie S
Publication type:
Letter to the Editor
Effect of Body Weight and Age on the Pharmacokinetics of Dihydroartemisinin: Food and Drug Administration Basis for Dose Determination of Artesunate for Injection in Pediatric Patients With Severe Malaria.
Published in:
Clinical Infectious Diseases, 2021, v. 73, n. 5, p. 903, doi. 10.1093/cid/ciab149
By:
- Kitabi, Eliford;
- Bensman, Timothy J;
- Earp, Justin C;
- Chilukuri, Dakshina M;
- Smith, Heidi;
- Ball, Leslie;
- O'Shaughnessy, Elizabeth;
- Yasinskaya, Yuliya;
- Colangelo, Philip M;
- Reynolds, Kellie S
Publication type:
Article
Creating a Roadmap to Quantitative Systems Pharmacology–Informed Rare Disease Drug Development: A Workshop Report.
Published in:
Clinical Pharmacology & Therapeutics, 2024, v. 115, n. 2, p. 201, doi. 10.1002/cpt.3096
By:
- Bai, Jane P.F.;
- Stinchcomb, Audra L.;
- Wang, Jie;
- Earp, Justin;
- Stern, Sydney;
- Schuck, Robert N.
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
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.
Published in:
Clinical Pharmacology & Therapeutics, 2022, v. 111, n. 3, p. 624, doi. 10.1002/cpt.2445
By:
- Fan, Jianghong;
- Yang, Yuching;
- Grimstein, Manuela;
- Zhang, Xinyuan;
- Kitabi, Eliford;
- Earp, Justin C;
- Arya, Vikram;
- Reynolds, Kellie S;
- Zhu, Hao;
- Wang, Yaning
Publication type:
Article
A Simulation Approach to Evaluate the Impact of Patterns of Bioanalytical Bias Difference on the Outcome of Pharmacokinetic Similarity Studies.
Published in:
Clinical Pharmacology & Therapeutics, 2020, v. 108, n. 1, p. 107, doi. 10.1002/cpt.1767
By:
- Obianom, Obinna N.;
- Okusanya, Olanrewaju O.;
- Earp, Justin;
- Thway, Theingi M.
Publication type:
Article
Down-regulation of heat shock protein 70 improves arsenic trioxide and 17-DMAG effects on constitutive signal transducer and activator of transcription 3 activity.
Published in:
Cancer Chemotherapy & Pharmacology, 2010, v. 66, n. 4, p. 681, doi. 10.1007/s00280-009-1210-7
By:
- Ghoshal, Sampa;
- Rao, Indranil;
- Earp, Justin C.;
- Jusko, William J.;
- Wetzler, Meir
Publication type:
Article
Quantitative systems pharmacology: Landscape analysis of regulatory submissions to the US Food and Drug Administration.
Published in:
CPT: Pharmacometrics & Systems Pharmacology, 2021, v. 10, n. 12, p. 1479, doi. 10.1002/psp4.12709
By:
- Bai, Jane P. F.;
- Earp, Justin C.;
- Florian, Jeffry;
- Madabushi, Rajanikanth;
- Strauss, David G.;
- Wang, Yaning;
- Zhu, Hao
Publication type:
Article
Anti–SARS‐CoV‐2 Repurposing Drug Database: Clinical Pharmacology Considerations.
Published in:
CPT: Pharmacometrics & Systems Pharmacology, 2021, v. 10, n. 9, p. 973, doi. 10.1002/psp4.12681
By:
- 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
Publication type:
Article
A Perspective on Quantitative Systems Pharmacology Applications to Clinical Drug Development.
Published in:
CPT: Pharmacometrics & Systems Pharmacology, 2020, v. 9, n. 12, p. 675, doi. 10.1002/psp4.12567
By:
- Bai, Jane P. F.;
- Earp, Justin C.;
- Strauss, David G.;
- Zhu, Hao
Publication type:
Article
Impact of Pharmacometric Analyses on New Drug Approval and Labelling Decisions.
Published in:
Clinical Pharmacokinetics, 2011, v. 50, n. 10, p. 627, doi. 10.2165/11593210-000000000-00000
By:
- Joo Yeon Lee;
- Garnett, Christine E.;
- Gobburu, Jogarao V. S.;
- Bhattaram, Venkatesh A.;
- Brar, Satjit;
- Earp, Justin C.;
- Jadhav, Pravin R.;
- Krudys, Kevin;
- Lesko, Lawrence J.;
- Fang Li;
- Jiang Liu;
- Madabushi, Rajnikanth;
- Marathe, Anshu;
- Mehrotra, Nitin;
- Tornoe, Christoffer;
- Yaning Wang;
- Hao Zhu
Publication type:
Article
Utility of population pharmacokinetic modeling in the assessment of therapeutic protein-drug interactions.
Published in:
Journal of Clinical Pharmacology, 2014, v. 54, n. 5, p. 593, doi. 10.1002/jcph.240
By:
- Chow, Andrew T.;
- Earp, Justin C.;
- Gupta, Manish;
- Hanley, William;
- Hu, Chuanpu;
- Wang, Diane D.;
- Zajic, Stefan;
- Zhu, Min
Publication type:
Article
Methods and strategies for assessing uncontrolled drug-drug interactions in population pharmacokinetic analyses: results from the International Society of Pharmacometrics (ISOP) Working Group.
Published in:
Journal of Pharmacokinetics & Pharmacodynamics, 2016, v. 43, n. 2, p. 123, doi. 10.1007/s10928-016-9464-2
By:
- Bonate, Peter;
- Ahamadi, Malidi;
- Budha, Nageshwar;
- Peña, Amparo;
- Earp, Justin;
- Hong, Ying;
- Karlsson, Mats;
- Ravva, Patanjali;
- Ruiz-Garcia, Ana;
- Struemper, Herbert;
- Wade, Janet
Publication type:
Article
Esomeprazole FDA Approval in Children With GERD: Exposure-Matching and Exposure-Response.
Published in:
2017
By:
- Earp, Justin C.;
- Mehrotra, Nitin;
- Peters, Kristina E.;
- Fiorentino, Robert P.;
- Griebel, Donna;
- Lee, Sue C.;
- Mulberg, Andrew;
- Röhss, Kerstin;
- Sandström, Marie;
- Taylor, Amy;
- Tornøe, Christoffer W.;
- Wynn, Erica L.;
- Van der Walt, Jan-Stefan;
- Garnett, Christine
Publication type:
journal article
Application of Model‐Informed Drug Development in Dose Selection and Optimization for siRNA Therapies.
Published in:
Journal of Clinical Pharmacology, 2024, v. 64, n. 7, p. 799, doi. 10.1002/jcph.2418
By:
- Yuan, Ye;
- Li, Liang;
- Earp, Justin;
- Ma, Lian;
- Bhattaram, Venkatesh Atul;
- Sharma, Vishnu;
- Tong, Alexander;
- Wang, Yaning;
- Liu, Jiang;
- Zhu, Hao
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
Considerations and Challenges in the Remdesivir COVID-19 Pediatric Development Program.
Published in:
Journal of Clinical Pharmacology, 2023, v. 63, n. 2, p. 259, doi. 10.1002/jcph.2158
By:
- Chan-Tack, Kirk;
- Sampson, Mario;
- Earp, Justin;
- Arya, Vikram;
- Yao, Lynne;
- Alexander, John;
- Hausman, Ethan;
- Belew, Yodit;
- Birnkrant, Debra;
- Struble, Kimberly
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
The Utility of a Population Approach in Drug-Drug Interaction Assessments: A Simulation Evaluation.
Published in:
Journal of Clinical Pharmacology, 2017, v. 57, n. 10, p. 1268, doi. 10.1002/jcph.921
By:
- Wang, Diane D.;
- Yu, Yanke;
- Kassir, Nastya;
- Zhu, Min;
- Hanley, William D.;
- Earp, Justin C.;
- Chow, Andrew T.;
- Gupta, Manish;
- Hu, Chuanpu
Publication type:
Article
PK in Late Phase Trials.
Published in:
Applied Clinical Trials, 2012, v. 21, n. 2, p. 40
By:
- Mehrotra, Nitin;
- Yaning Wang;
- Bhattaram, Venkatesh A.;
- Earp, Justin C.;
- Florian, Jeffry;
- Garnett, Christine;
- Jadhav, Pravin R.;
- Krudys, Kevin;
- Joo-Yeon Lee;
- Fang Li;
- Jiang Liu;
- Madabushi, Rajnikanth;
- Marathe, Anshu;
- Tornoe, Christoffer W.;
- Hao Zhu;
- Gobburu, Jogarao V.
Publication type:
Article
Quantitative Dynamic Models of Arthritis Progression in the Rat.
Published in:
Pharmaceutical Research, 2009, v. 26, n. 1, p. 196, doi. 10.1007/s11095-008-9711-3
By:
- Justin Earp
Publication type:
Article

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