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Clinical pharmacology applications in clinical drug development and clinical care: A focus on Saudi Arabia
Saudi Pharmaceutical Journal ( IF 3.0 ) Pub Date : 2020-08-21 , DOI: 10.1016/j.jsps.2020.08.012
Abdullah Alsultan , Wael A. Alghamdi , Jahad Alghamdi , Abeer F. Alharbi , Abdullah Aljutayli , Ahmed Albassam , Omar Almazroo , Saeed Alqahtani

Drug development, from preclinical to clinical studies, is a lengthy and complex process. There is an increased interest in the Kingdom of Saudi Arabia (KSA) to promote innovation, research and local content including clinical trials (Phase I-IV). Currently, there are over 650 registered clinical trials in Saudi Arabia, and this number is expected to increase. An important part of drug development and clinical trials is to assure the safe and effective use of drugs. Clinical pharmacology plays a vital role in informed decision making during the drug development stage as it focuses on the effects of drugs in humans. Disciplines such as pharmacokinetics, pharmacodynamics and pharmacogenomics are components of clinical pharmacology. It is a growing discipline with a range of applications in all phases of drug development, including selecting optimal doses for Phase I, II and III studies, evaluating bioequivalence and biosimilar studies and designing clinical studies. Incorporating clinical pharmacology in research as well as in the requirements of regulatory agencies will improve the drug development process and accelerate the pipeline. Clinical pharmacology is also applied in direct patient care with the goal of personalizing treatment. Tools such as therapeutic drug monitoring, pharmacogenomics and model informed precision dosing are used to optimize dosing for patients at an individual level. In KSA, the science of clinical pharmacology is underutilized and we believe it is important to raise awareness and educate the scientific community and healthcare professionals in terms of its applications and potential. In this review paper, we provide an overview on the use and applications of clinical pharmacology in both drug development and clinical care.



中文翻译:

临床药理学在临床药物开发和临床护理中的应用:以沙特阿拉伯为重点

从临床前研究到临床研究,药物开发是一个漫长而复杂的过程。沙特阿拉伯王国(KSA)对促进创新,研究和包括临床试验(阶段I-IV)在内的本地内容的兴趣日益浓厚。目前,沙特阿拉伯有650多项注册的临床试验,并且这一数字预计还会增加。药物开发和临床试验的重要组成部分是确保安全有效地使用药物。临床药理学在药物开发阶段的明智决策中起着至关重要的作用,因为它着重于药物对人类的影响。诸如药代动力学,药效学和药物基因组学等学科是临床药理学的组成部分。这是一门发展中的学科,在药物开发的各个阶段都有广泛的应用,包括为I,II和III期研究选择最佳剂量,评估生物等效性和生物仿制药研究以及设计临床研究。将临床药理学纳入研究以及监管机构的要求中将改善药物开发过程并加快开发流程。临床药理学也可用于个性化治疗的直接患者护理中。使用诸如治疗药物监控,药物基因组学和模型告知的精确剂量之类的工具来优化患者个体水平的剂量。在KSA中,临床药理学没有得到充分利用,我们认为在其应用和潜力方面提高认识并教育科学界和医疗保健专业人员非常重要。在这篇评论文章中,

更新日期:2020-10-30
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