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Understanding effect site pharmacology of uprifosbuvir a hepatitis C virus nucleoside inhibitor: Case study of a multidisciplinary modeling approach in drug development

机译：理解uprifosbuvir丙型肝炎病毒核苷抑制剂的效果植物药理学：案例研究药物开发中多学科建模方法

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Uprifosbuvir is a uridine nucleoside monophosphate prodrug inhibitor of the hepatitis C virus NS5B RNA polymerase. To quantitatively elucidate key metabolic pathways, assess the link between unmeasurable effect site concentrations and viral load reduction, and evaluate the influence of intrinsic and extrinsic factors on pharmacokinetics and pharmacodynamics, a model‐informed drug development (MIDD) framework was initiated at an early stage. Originally scoped as a modeling effort focused on minimal physiologically based pharmacokinetic and covariate analyses, this project turned into a collaborative effort focused on gaining a deeper understanding of the data from drug metabolism, biopharmaceutics, pharmacometrics, and clinical pharmacology perspectives. This article presents an example of the practical execution of a MIDD‐based, cooperative multidisciplinary modeling approach, creating a model that grows along with the team's integrated knowledge. Insights gained from this process could be used in forming optimal collaborations between disciplines in drug development for other investigative compounds.

机译：Uprifosbuvir是丙啶核苷的单磷酸盐前药抑制剂的丙型肝炎病毒NS5B RNA聚合酶。为了定量阐明关键的代谢途径，评估未衡量的效果部位浓度和病毒载量之间的联系，并评估内在和外在因素对药代动力学和药效学的影响，在早期发起了一个模型知情的药物发展（MIDD）框架。本项目最初是专注于最小的生理学药代动力学和协变量分析的建模努力，该项目变成了一项合作努力，重点是对来自药物新陈代谢，生物药物，药物测量学和临床药理学观点的数据的更深入了解。本文提出了一个实际执行基于中等的合作多学科建模方法的示例，创建了一个与团队的综合知识一起增长的模型。从该过程中获得的见解可用于在其他调查化合物的药物开发中的学科之间形成最佳的合作。

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期刊名称 CPT: Pharmacometrics Systems Pharmacology
作者
Paul van den Berg; Wei Gao; Maurice J. Ahsman; Leticia Arrington; Filippos Kesisoglou; Randy Miller; Teun M. Post; Matthew L. Rizk;
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作者单位

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年(卷),期 2021(10),7
年度 2021
页码 658–670
总页数 13
原文格式 PDF
正文语种
中图分类药学;
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专利

1. Efficacy and safety of a two‐drug direct‐acting antiviral agent regimen ruzasvir 180?mg and uprifosbuvir 450?mg for 12?weeks in adults with chronic hepatitis C virus genotype 1, 2, 3, 4, 5 or 6 [J] . Lawitz Eric, Gane Edward, Feld Jordan J., Journal of viral hepatitis. . 2019,第9期

机译：双药直立抗病毒药物的疗效和安全性ruzasvir 180？mg和uprifosbuvir 450？mg在慢性丙型肝炎病毒基因型1,2,3,4,5或6的成人中为12？
2. C-BREEZE 2: Efficacy and Safety of a Two-Drug Direct-Acting Antiviral Agent (DAA) Regimen Ruzasvir 180 mg and Uprifosbuvir 450 mg for 12 Weeks in Adults With Chronic Hepatitis C Virus (HCV) Genotype (GT) 1, 2, 3, 4, or 6 [J] . Lawitz Eric, Gane Edward J., Feld Jordan J., Hepatology: Official Journal of the American Association for the Study of Liver Diseases . 2017,第Suppla1期

机译：C-Breeze 2：双药直起抗病毒药物（DAA）ruzasvir 180mg和Uprifosbuvir 450mg的疗效和安全性在成人中12周，慢性丙型肝炎病毒（HCV）基因型（GT）1,2， 3,4或6
3. Understanding the drug resistance mechanism of hepatitis C virus NS5B to PF-00868554 due to mutations of the 423 site: a computational study [J] . Pingzu Jiao, Weiwei Xue, Yulin Shen, Molecular BioSystems . 2014,第4期

机译：通过423个位点的突变了解丙型肝炎病毒NS5B对PF-00868554的耐药机制：一项计算研究
4. Prime site binding inhibitors of the hepatitis C virus NS3/4A serine protease [C] . Elisabetta Bianchi, Paolo Ingallinella, Daniela Fattori, the International Peptide Symposium . 2001

机译：丙型肝炎病毒NS3 / 4A丝氨酸蛋白酶的素位点结合抑制剂
5. Mechanistic understanding of nucleoside inhibitors of human immunodeficiency virus (HIV). [D] . Ray, Adrian Staffin. 2002

机译：对人类免疫缺陷病毒（HIV）核苷抑制剂的机械理解。
6. Imino sugars inhibit the formation and secretion of bovine viral diarrhea virus a pestivirus model of hepatitis C virus: Implications for the development of broad spectrum anti-hepatitis virus agents [O] . Nicole Zitzmann, Anand S. Mehta, Sandra Carrouée, 1999

机译：氨基糖抑制牛病毒性腹泻病毒（丙型肝炎病毒的瘟病毒模型）的形成和分泌：对广谱抗肝炎病毒制剂的开发具有重要意义
7. Understanding effect site pharmacology of uprifosbuvir, a hepatitis C virus nucleoside inhibitor: Case study of a multidisciplinary modeling approach in drug development [O] . Paul van den Berg, Wei Gao, Maurice J. Ahsman, 2021

机译：理解uprifosbuvir，丙型肝炎病毒核苷抑制剂的效果植物药理学：案例研究药物开发中多学科建模方法

Understanding effect site pharmacology of uprifosbuvir a hepatitis C virus nucleoside inhibitor: Case study of a multidisciplinary modeling approach in drug development

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