Výsledky vyhledávání - "Justin C, Earp"

Akademický článek

Quantitative systems pharmacology: Landscape analysis of regulatory submissions to the US Food and Drug Administration

Autor: Jane P. F. Bai, Justin C. Earp, Jeffry Florian, Rajanikanth Madabushi, David G. Strauss, Yaning Wang, Hao Zhu

Publikováno v: CPT: Pharmacometrics & Systems Pharmacology, Vol 10, Iss 12, Pp 1479-1484 (2021)

Abstract Quantitative systems pharmacology (QSP) has been proposed as a scientific domain that can enable efficient and informative drug development. During the past several years, there has been a notable increase in the number of regulatory submiss

Externí odkaz: https://doaj.org/article/6daa584ed9f24da285c2282c62134c68

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Model‐Informed Drug Development Approaches to Assist New Drug Development in the COVID‐19 Pandemic

Autor: Justin C. Earp, Nan Zheng, Eliford Kitabi, Yuching Yang, Manuela Grimstein, Jiang Liu, Yaning Wang, Jianghong Fan, Hao Zhu, Youwei Bi, Xinyuan Zhang, Ye Xiong

Publikováno v: Clinical Pharmacology & Therapeutics. 111:572-578

Leveraging limited clinical and nonclinical data through modeling approaches facilitates new drug development and regulatory decision making amid the coronavirus disease 2019 (COVID-19) pandemic. Model-informed drug development (MIDD) is an essential

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::70b1bae439e49cb05f4e0790a667ce7d
https://doi.org/10.1002/cpt.2491

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Utility of islet autoantibodies as enrichment biomarkers in type 1 diabetes clinical studies: a viewpoint from the FDA

Autor: Justin, Penzenstadler, Justin C, Earp, Lauren K, Wood Heickman, Kristen, Pluchino

Publikováno v: Diabetologia.

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=pmid________::d4961898be04b14e94287c743cc339ae
https://pubmed.ncbi.nlm.nih.gov/36542112

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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

Autor: Vikram Arya, Xinyuan Zhang, Justin C. Earp, Kellie S. Reynolds, Yaning Wang, Manuela Grimstein, Hao Zhu, Yuching Yang, Eliford Kitabi, Jianghong Fan

Publikováno v: Clinical Pharmacology & Therapeutics. 111:624-634

Remdesivir (RDV) is the first drug approved by the US Food and Drug Administration (FDA) for the treatment of coronavirus disease 2019 (COVID-19) in certain patients requiring hospitalization. As a nucleoside analogue prodrug, RDV undergoes intracell

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::6dbff2b27a48eab542615954b8b8f186
https://doi.org/10.1002/cpt.2445

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Quantitative systems pharmacology: Landscape analysis of regulatory submissions to the US Food and Drug Administration

Autor: David G. Strauss, Yaning Wang, Jane P. F. Bai, Hao Zhu, Justin C. Earp, Jeffry Florian, Rajanikanth Madabushi

Publikováno v: CPT: Pharmacometrics & Systems Pharmacology, Vol 10, Iss 12, Pp 1479-1484 (2021)
CPT: Pharmacometrics & Systems Pharmacology

Quantitative systems pharmacology (QSP) has been proposed as a scientific domain that can enable efficient and informative drug development. During the past several years, there has been a notable increase in the number of regulatory submissions that

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::55b70fb3e51cb959e9953eb173a38952
https://doi.org/10.1002/psp4.12709

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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

Autor: Justin C. Earp, Eliford Kitabi, Dakshina Chilukuri, Timothy J Bensman, Elizabeth O’Shaughnessy, Leslie Ball, Philip M Colangelo, Yuliya Yasinskaya, Kellie S. Reynolds, Heidi Smith

Publikováno v: Clinical Infectious Diseases. 73:903-906

For treatment of severe malaria, the World Health Organization recommends 3 mg/kg intravenous artesunate in pediatric patients weighing less than 20 kg. Here we describe the Food and Drug Administration’s rationale for selecting 2.4 mg/kg in pediat

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::23f18c46a84618e71c9937cae2bc0065
https://doi.org/10.1093/cid/ciab149

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A Simulation Approach to Evaluate the Impact of Patterns of Bioanalytical Bias Difference on the Outcome of Pharmacokinetic Similarity Studies

Autor: Obinna N. Obianom, Theingi M. Thway, Olanrewaju O. Okusanya, Justin C. Earp

Publikováno v: Clinical Pharmacology & Therapeutics. 108:107-115

Pharmacokinetic (PK) similarity studies are vital to assess the biosimilarity of a biosimilar to a reference product. Systematic bias in a bioanalytical method that quantify products could be a potential source of error affecting the variability of t

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::37d0e66c0238720e44a0502c774b5915
https://doi.org/10.1002/cpt.1767

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