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Off-Label Therapies for COVID-19-Are We All In This Together?新冠病毒病的非标签疗法——我们同舟共济？
Clin Pharmacol Ther. 2020 Aug;108(2):182-184. doi: 10.1002/cpt.1862. Epub 2020 May 5.
2
Optimizing Hydroxychloroquine Dosing for Patients With COVID-19: An Integrative Modeling Approach for Effective Drug Repurposing.优化 COVID-19 患者的羟氯喹剂量：一种有效的药物再利用的综合建模方法。
Clin Pharmacol Ther. 2020 Aug;108(2):253-263. doi: 10.1002/cpt.1856. Epub 2020 May 12.
3
Considerations for Drug Interactions on QTc in Exploratory COVID-19 Treatment.探索性新冠肺炎治疗中药物相互作用对QTc的影响因素
Circulation. 2020 Jun 16;141(24):e906-e907. doi: 10.1161/CIRCULATIONAHA.120.047521. Epub 2020 Apr 8.
4
Towards Optimization of Hydroxychloroquine Dosing in Intensive Care Unit COVID-19 Patients.优化重症监护病房新冠肺炎患者羟氯喹的给药方案
Clin Infect Dis. 2020 Nov 19;71(16):2227-2229. doi: 10.1093/cid/ciaa394.
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Coronavirus Disease 2019 (COVID-19): Do Angiotensin-Converting Enzyme Inhibitors/Angiotensin Receptor Blockers Have a Biphasic Effect?2019冠状病毒病（COVID-19）：血管紧张素转换酶抑制剂/血管紧张素受体阻滞剂是否具有双相效应？
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In Vitro Antiviral Activity and Projection of Optimized Dosing Design of Hydroxychloroquine for the Treatment of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2).羟氯喹治疗严重急性呼吸综合征冠状病毒 2 （SARS-CoV-2）的体外抗病毒活性和优化剂量设计预测。
Clin Infect Dis. 2020 Jul 28;71(15):732-739. doi: 10.1093/cid/ciaa237.
7
Multistate modeling of clinical hold in randomized clinical trials.多州临床试验中临床搁置的多状态建模。
Pharm Stat. 2020 May;19(3):262-275. doi: 10.1002/pst.1989. Epub 2019 Dec 10.
8
Wearable Devices in Clinical Trials: Hype and Hypothesis.可穿戴设备在临床试验中的应用：炒作与假设。
Clin Pharmacol Ther. 2018 Jul;104(1):42-52. doi: 10.1002/cpt.966. Epub 2018 Apr 2.

新冠疫情给药物研发带来的挑战：临床药理学的机遇。

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

机构信息

EMD Serono Research & Development Institute, Inc., Billerica, Massachusetts, USA.

Business of Merck KGaA, Darmstadt, Germany.

出版信息

Clin Pharmacol Ther. 2020 Oct;108(4):699-702. doi: 10.1002/cpt.1879. Epub 2020 May 28.

DOI:10.1002/cpt.1879
PMID:32356569
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7267567/
Abstract

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) approaching therapeutic dilemmas in clinical trial settings, and (iii) maximizing value of information from impacted non-COVID-19 trials. More than ever, we have a responsibility for adaptive evidence synthesis with a Totality of Evidence mindset in this race against time across biomedical research, clinical practice, drug development, and regulation.

摘要

由 2019 年冠状病毒病（COVID-19）大流行带来的前所未有的挑战突显了临床药理学和基于模型的药物开发在以下方面的紧迫性：（i）COVID-19 治疗的剂量优化，（ii）在临床试验环境中解决治疗难题，以及（iii）从受影响的非 COVID-19 试验中最大限度地获取信息。在这场与时间赛跑的生物医学研究、临床实践、药物开发和监管的竞赛中，我们比以往任何时候都更有责任采用基于全证据的适应性证据综合方法。