Model-informed drug discovery and development approaches to inform clinical trial design and regulatory decisions: A primer for the MENA region

IF 3 3区医学 Q2 PHARMACOLOGY & PHARMACY

Saudi Pharmaceutical Journal Pub Date : 2024-11-21 DOI:10.1016/j.jsps.2024.102207

Mohammed S. Alasmari , Salwa Albusaysi , Marwa Elhefnawy , Ali M. Ali , Khalid Altigani , Mohammed Almoslem , Mohammed Alharbi , Jahad Alghamdi , Abdullah Alsultan

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引用次数: 0

Abstract

Model-Informed Drug Discovery and Development (MID3) represents a transformative approach in pharmaceutical research, integrating quantitative models to inform and optimize decision-making throughout the drug development process. This review explores the current applications, challenges, and future prospects of MID3 within the Middle East and North Africa (MENA) region. By leveraging local data and advanced computational techniques, MID3 has the potential to significantly enhance the efficiency and success rates of drug development tailored to regional health priorities. We discussed successful case studies of applying MID3 at different phases of drug development and clinical trials. Furthermore, we emphasized the critical need for MENA countries to embrace MID3 by investing in workforce training, aligning regulatory frameworks, and fostering collaborative research initiatives. This call to action underscores the importance of a robust MID3 ecosystem, urging policymakers, academic institutions, and industry stakeholders to prioritize and support its integration into the MENA region’s healthcare.

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以模型为依据的药物发现和开发方法，为临床试验设计和监管决策提供信息：中东和北非地区入门指南

模型信息药物发现与开发 (MID3) 是制药研究领域的一种变革性方法，它整合了定量模型，为整个药物开发过程提供信息并优化决策。本综述探讨了 MID3 在中东和北非地区的当前应用、挑战和未来前景。通过利用本地数据和先进的计算技术，MID3 有可能显著提高针对地区健康优先事项的药物开发效率和成功率。我们讨论了在药物开发和临床试验的不同阶段应用 MID3 的成功案例研究。此外，我们还强调中东和北非国家亟需通过投资劳动力培训、调整监管框架和促进合作研究计划来接受 MID3。这一行动呼吁强调了建立一个强大的 MID3 生态系统的重要性，敦促政策制定者、学术机构和行业利益相关者优先考虑并支持将 MID3 纳入中东和北非地区的医疗保健领域。

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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来源期刊

Saudi Pharmaceutical Journal PHARMACOLOGY & PHARMACY-

CiteScore

6.10

自引率

2.40%

发文量

194

审稿时长

67 days

期刊介绍： The Saudi Pharmaceutical Journal (SPJ) is the official journal of the Saudi Pharmaceutical Society (SPS) publishing high quality clinically oriented submissions which encompass the various disciplines of pharmaceutical sciences and related subjects. SPJ publishes 8 issues per year by the Saudi Pharmaceutical Society, with the cooperation of the College of Pharmacy, King Saud University.