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Review
. 2020 Oct;28(10):1217-1227.
doi: 10.1016/j.jsps.2020.08.012. Epub 2020 Aug 21.

Clinical pharmacology applications in clinical drug development and clinical care: A focus on Saudi Arabia

Abdullah Alsultan  1   2 , Wael A Alghamdi  3 , Jahad Alghamdi  4 , Abeer F Alharbi  5 , Abdullah Aljutayli  6 , Ahmed Albassam  7 , Omar Almazroo  8 , Saeed Alqahtani  1   2
Affiliations
Review

Clinical pharmacology applications in clinical drug development and clinical care: A focus on Saudi Arabia

Abdullah Alsultan et al. Saudi Pharm J. 2020 Oct.

Abstract

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.

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Conflict of interest statement

The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

Figures

Fig. 1
Fig. 1
Number of registered clinical trials in Saudi Arabia.
Fig. 2
Fig. 2
The number of publications with the term “population pharmacokinetics” from 1980 to 2015.
See this image and copyright information in PMC

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