培训下一代药物计量学建模人员:多部门视角。

IF 2.2 4区 医学 Q3 PHARMACOLOGY & PHARMACY Journal of Pharmacokinetics and Pharmacodynamics Pub Date : 2024-02-01 Epub Date: 2023-08-13 DOI:10.1007/s10928-023-09878-4
Peter L Bonate, Jeffrey S Barrett, Sihem Ait-Oudhia, Richard Brundage, Brian Corrigan, Stephen Duffull, Marc Gastonguay, Mats O Karlsson, Shinichi Kijima, Andreas Krause, Mark Lovern, Matthew M Riggs, Michael Neely, Daniele Ouellet, Elodie L Plan, Gauri G Rao, Joseph Standing, Justin Wilkins, Hao Zhu
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引用次数: 0

摘要

目前对药物计量学人员的需求超过了学术机构的供应量,因此需要大量投资来培养这些科学家的在职能力。即使药物计量学相关的学术课程有所增加,这种需求在可预见的未来也不太可能改变,因为药物计量学的需求和应用范围在不断扩大。此外,药物计量学领域也在不断变化。该领域主要始于 Lewis Sheiner 和 Stuart Beal 在 20 世纪 70 年代末和 80 年代初发表的关于群体药物动力学的开创性论文,自诞生以来,其影响和应用不断扩大。在过去十年中,基于生理的药代动力学和系统药理学在范围和影响上都得到了迅速发展,而机器学习则刚刚起步。虽然所有这些方法都被归类为药物计量学,但没有一个人可以成为所有方面的专家。那么,如何培养未来的药物计量学专家呢?学术界、工业界、合同研究组织、临床医学和监管部门的顶尖专家就如何最好地培训未来的药物计量学家发表了自己的意见。我们收集并综合了他们的意见,提出了一些一般性建议。
本文章由计算机程序翻译,如有差异,请以英文原文为准。

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Training the next generation of pharmacometric modelers: a multisector perspective.

The current demand for pharmacometricians outmatches the supply provided by academic institutions and considerable investments are made to develop the competencies of these scientists on-the-job. Even with the observed increase in academic programs related to pharmacometrics, this need is unlikely to change in the foreseeable future, as the demand and scope of pharmacometrics applications keep expanding. Further, the field of pharmacometrics is changing. The field largely started when Lewis Sheiner and Stuart Beal published their seminal papers on population pharmacokinetics in the late 1970's and early 1980's and has continued to grow in impact and use since its inception. Physiological-based pharmacokinetics and systems pharmacology have grown rapidly in scope and impact in the last decade and machine learning is just on the horizon. While all these methodologies are categorized as pharmacometrics, no one person can be an expert in everything. So how do you train future pharmacometricians? Leading experts in academia, industry, contract research organizations, clinical medicine, and regulatory gave their opinions on how to best train future pharmacometricians. Their opinions were collected and synthesized to create some general recommendations.

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来源期刊
CiteScore
4.90
自引率
4.00%
发文量
39
审稿时长
6-12 weeks
期刊介绍: Broadly speaking, the Journal of Pharmacokinetics and Pharmacodynamics covers the area of pharmacometrics. The journal is devoted to illustrating the importance of pharmacokinetics, pharmacodynamics, and pharmacometrics in drug development, clinical care, and the understanding of drug action. The journal publishes on a variety of topics related to pharmacometrics, including, but not limited to, clinical, experimental, and theoretical papers examining the kinetics of drug disposition and effects of drug action in humans, animals, in vitro, or in silico; modeling and simulation methodology, including optimal design; precision medicine; systems pharmacology; and mathematical pharmacology (including computational biology, bioengineering, and biophysics related to pharmacology, pharmacokinetics, orpharmacodynamics). Clinical papers that include population pharmacokinetic-pharmacodynamic relationships are welcome. The journal actively invites and promotes up-and-coming areas of pharmacometric research, such as real-world evidence, quality of life analyses, and artificial intelligence. The Journal of Pharmacokinetics and Pharmacodynamics is an official journal of the International Society of Pharmacometrics.
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Novel endpoints based on tumor size ratio to support early clinical decision-making in oncology drug-development. Translational pharmacokinetic and pharmacodynamic modelling of the anti-ADAMTS-5 NANOBODY® (M6495) using the neo-epitope ARGS as a biomarker. QSP modeling of a transiently inactivating antibody-drug conjugate highlights benefit of short antibody half life. A PopPBPK-RL approach for precision dosing of benazepril in renal impaired patients. Comparison of the power and type 1 error of total score models for drug effect detection in clinical trials.
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