Výsledky vyhledávání - "Jennifer Q. Dong"

Akademický článek

Risk assessment of drug–drug interaction potential for bintrafusp alfa with cytochrome P4503A4 substrates: A totality of evidence approach

Autor: Yulia Vugmeyster, George Locke, Christoph Helwig, P. Alexander Rolfe, Jennifer Q. Dong, Karthik Venkatakrishnan

Publikováno v: Clinical and Translational Science, Vol 15, Iss 12, Pp 2838-2843 (2022)

Abstract Bintrafusp alfa, a first‐in‐class bifunctional fusion protein composed of the extracellular domain of TGF‐βRII (a TGF‐β “trap”) fused to a human IgG1 mAb blocking PD‐L1, is being evaluated for efficacy and safety in solid tum

Externí odkaz: https://doaj.org/article/e15fa39037b049629cd34c94547a2625

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Applying Modeling and Simulations for Rational Dose Selection of Novel Toll‐Like Receptor 7/8 Inhibitor Enpatoran for Indications of High Medical Need

Autor: Lena, Klopp-Schulze, Jamie V, Shaw, Jennifer Q, Dong, Akash, Khandelwal, Cristina, Vazquez-Mateo, Kosalaram, Goteti

Publikováno v: Clinical Pharmacology & Therapeutics. 112:297-306

Dual toll-like receptor (TLR) 7 and TLR8 inhibitor enpatoran is under investigation as a treatment for lupus and coronavirus disease 2019 (COVID-19) pneumonia. Population pharmacokinetic/pharmacodynamic (PopPK/PD) model-based simulations, using PK an

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::e2d89bc37fec6cb6e33501a975b5d55f
https://doi.org/10.1002/cpt.2606

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Challenges in Drug Development Posed by the COVID‐19 Pandemic: An Opportunity for Clinical Pharmacology

Autor: Oezkan Yalkinoglu, Karthik Venkatakrishnan, Jennifer Q. Dong, Lisa J. Benincosa

Publikováno v: Clinical Pharmacology and Therapeutics
Clinical Pharmacology & Therapeutics

The unprecedented challenges posed by the coronavirus disease 2019 (COVID‐19) pandemic highlight the urgency for applying clinical pharmacology and model‐informed drug development in (i) dosage optimization for COVID‐19 therapies, (ii) approach

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::689ab24bf63d5d1cd414cb37749767fb
https://doi.org/10.1002/cpt.1879

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Once‐weekly administration of a long‐acting fibroblast growth factor 21 analogue modulates lipids, bone turnover markers, blood pressure and body weight differently in obese people with hypertriglyceridaemia and in non‐human primates

Autor: Saswata Talukdar, Yan Weng, Jennifer Q. Dong, Veena Somayaji, Timothy P. Rolph, Jeffrey R. Chabot, Roberto A. Calle, Kathryn E. Gropp, Albert M. Kim

Publikováno v: Diabetes, Obesity and Metabolism. 19:1762-1772

Aims To assess the safety, tolerability, pharmacokinetics and pharmacodynamics of PF-05231023, a long-acting FGF21 analogue, in obese, hypertriglyceridemic subjects on atorvastatin with or without type 2 diabetes. Methods Subjects received PF-0523102

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::abaf3205a68464fc35266617906d9b22
https://doi.org/10.1111/dom.13023

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Examination of the Human Cytochrome P4503A4 Induction Potential of PF-06282999, an Irreversible Myeloperoxidase Inactivator: Integration of Preclinical, In Silico, and Biomarker Methodologies in the Prediction of the Clinical Outcome

Autor: James R. Gosset, Zhiwu Lin, Jeffrey R. Chabot, Odette A. Fahmi, Albert M. Kim, Vu Le, Parya Nouri, Amit S. Kalgutkar, Steven G. Terra, Leonard Buckbinder, Jennifer Q. Dong, Kristin Chidsey

Publikováno v: Drug Metabolism and Disposition. 45:501-511

The propensity for CYP3A4 induction by 2-(6-(5-chloro-2-methoxyphenyl)-4-oxo-2-thioxo-3,4-dihydropyrimidin-1(2H)-yl)acetamide (PF-06282999), an irreversible inactivator of myeloperoxidase, was examined in the present study. Studies using human hepato

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::d5f66b7e444e3d1890b02b39832bfc45
https://doi.org/10.1124/dmd.116.074476

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Standardized Mixed-Meal Tolerance and Arginine Stimulation Tests Provide Reproducible and Complementary Measures of β-Cell Function: Results From the Foundation for the National Institutes of Health Biomarkers Consortium Investigative Series

Publikováno v: Diabetes Care

OBJECTIVE Standardized, reproducible, and feasible quantification of β-cell function (BCF) is necessary for the evaluation of interventions to improve insulin secretion and important for comparison across studies. We therefore characterized the resp

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::6f954e13357939b8f3878693ffe12dfe
https://doi.org/10.2337/dc15-0931

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A Long-Acting FGF21 Molecule, PF-05231023, Decreases Body Weight and Improves Lipid Profile in Non-human Primates and Type 2 Diabetic Subjects

Autor: Adhiraj Lanba, Yan Weng, Veena Somayaji, Ronald W. Clark, Michelle Rossulek, Jeffrey R. Chabot, Dongmei Li, Derek M. Erion, Bryan Goodwin, Martin B. Brenner, Yingjiang Zhou, Saswata Talukdar, Bryn M. Owen, Kathryn E. Gropp, Roberto A. Calle, Timothy P. Rolph, Jennifer Q. Dong, Jeffrey K. Trimmer

Publikováno v: Cell Metabolism. 23:427-440

FGF21 plays a central role in energy, lipid, and glucose homeostasis. To characterize the pharmacologic effects of FGF21, we administered a long-acting FGF21 analog, PF-05231023, to obese cynomolgus monkeys. PF-05231023 caused a marked decrease in fo

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::e97c7e39399f40d27c9cbf82d950cf0d
https://doi.org/10.1016/j.cmet.2016.02.001

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Pharmacokinetics and Disposition of the Thiouracil Derivative PF-06282999, an Orally Bioavailable, Irreversible Inactivator of Myeloperoxidase Enzyme, Across Animals and Humans

Autor: Li Di, Bo Feng, Jennifer Q. Dong, Kazuko Sagawa, Tim F. Ryder, Manthena V.S. Varma, Steven G. Terra, Amit S. Kalgutkar, Angela Wolford

Publikováno v: Drug Metabolism and Disposition. 44:209-219

The thiouracil derivative PF-06282999 [2-(6-(5-chloro-2-methoxyphenyl)-4-oxo-2-thioxo-3,4-dihydropyrimidin-1(2H)-yl)acetamide] is an irreversible inactivator of myeloperoxidase and is currently in clinical trials for the potential treatment of cardio

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::cfca1f808303a6721d41a7358f78ad02
https://doi.org/10.1124/dmd.115.067868

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Pharmacokinetics and pharmacodynamics of PF-05231023, a novel long-acting FGF21 mimetic, in a first-in-human study

Autor: Martha Hernandez-Illas, Daniel Baltrukonis, Krischan Hudson, Michelle Rossulek, Roberto A. Calle, Veena Somayaji, Jennifer Q. Dong, Yali Liang

Publikováno v: British Journal of Clinical Pharmacology. 80:1051-1063

Aims The aim of the present study was to evaluate the pharmacokinetics/pharmacodynamics (PK/PD), safety and tolerability of single intravenous (IV) doses of PF-05231023, a long acting fibroblast growth factor 21 (FGF21) analogue being developed for t

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_________::226d43472e00c4df1887c64baf9318cd
https://doi.org/10.1111/bcp.12676

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Pharmacokinetics/Pharmacodynamics Model-Supported Early Drug Development

Autor: Bin Chen, Wei-Jian Pan, Jennifer Q. Dong, Ana Lúcia Tasca Gois Ruiz

Publikováno v: Current Pharmaceutical Biotechnology. 13:1360-1375

Pharmacokinetic/pharmacodynamic (PK/PD) modeling & simulation (M&S) provides quantitative assessment of dose/exposure-response relationships with extensive applications at the late stage drug development as well as during regulatory decision making.

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::70c5e7ceb297a595d4d2984c3debc2a1
https://doi.org/10.2174/138920112800624436

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