The American Society of Clinical Pharmacology and Therapeutics has defined clinical pharmacology as the “study of drugs in humans,” which is “underpinned by the basic science of pharmacology, with added focus on the application of pharmacological principles and methods in the real world”. In other words, clinical pharmacology focuses on the impact of intrinsic and extrinsic factors on inter-patient and intra-subject variability in drug exposure and response.
Ultimately, the aim of clinical pharmacology is to deliver the right drug to the right patient with the right dose at the right time.
Traditional clinical pharmacology methods involve primarily performing clinical trials to inform dosing strategies and to quantify the impact of patients’ factors on efficacy and safety. However, ethical and logistical challenges associated with performing clinical trials in children can limit research in pediatric clinical pharmacology.
Biological maturation involves growth, differentiation, and development, which extends from the preterm newborn infant through childhood, adolescence, and young adulthood. In the pediatric population due to age-dependent physiological changes and disease-mediated alterations, drug disposition and response can be significantly different from adults. In fact, in most cases, daily dosage requirements vary significantly with age. Disease related physiology and non-maturational covariates further complicate this setting.
Pharmacometric approaches and clinical decision support tools, leveraging in vitro studies, studies in juvenile animals, allometric scaling methods and/or available clinical data, have been applied to integrate patient and drug information and facilitate the advancement of pediatric clinical pharmacology. These tools have been shown to indeed result in better drug dosing in a target population.
The goal of this Research Topic is to highlight the application and the utility of advanced methods used in pediatric clinical pharmacology in comparison to the traditional when the aim is delivering information about safety and effectiveness in pediatric pharmacotherapy. The emphasis should be given on quantitative approaches that enable the improvement of pharmacotherapy in children and facilitate pediatric drug development.
This topic will focus on novel methods and their applications on pediatric clinical pharmacology. Original research or review papers related to novel quantitative methods or the application of quantitative analysis on in vitro, non-clinical or clinical data to understand drug disposition and/or response in children are welcome, and will be considered for publication.
The American Society of Clinical Pharmacology and Therapeutics has defined clinical pharmacology as the “study of drugs in humans,” which is “underpinned by the basic science of pharmacology, with added focus on the application of pharmacological principles and methods in the real world”. In other words, clinical pharmacology focuses on the impact of intrinsic and extrinsic factors on inter-patient and intra-subject variability in drug exposure and response.
Ultimately, the aim of clinical pharmacology is to deliver the right drug to the right patient with the right dose at the right time.
Traditional clinical pharmacology methods involve primarily performing clinical trials to inform dosing strategies and to quantify the impact of patients’ factors on efficacy and safety. However, ethical and logistical challenges associated with performing clinical trials in children can limit research in pediatric clinical pharmacology.
Biological maturation involves growth, differentiation, and development, which extends from the preterm newborn infant through childhood, adolescence, and young adulthood. In the pediatric population due to age-dependent physiological changes and disease-mediated alterations, drug disposition and response can be significantly different from adults. In fact, in most cases, daily dosage requirements vary significantly with age. Disease related physiology and non-maturational covariates further complicate this setting.
Pharmacometric approaches and clinical decision support tools, leveraging in vitro studies, studies in juvenile animals, allometric scaling methods and/or available clinical data, have been applied to integrate patient and drug information and facilitate the advancement of pediatric clinical pharmacology. These tools have been shown to indeed result in better drug dosing in a target population.
The goal of this Research Topic is to highlight the application and the utility of advanced methods used in pediatric clinical pharmacology in comparison to the traditional when the aim is delivering information about safety and effectiveness in pediatric pharmacotherapy. The emphasis should be given on quantitative approaches that enable the improvement of pharmacotherapy in children and facilitate pediatric drug development.
This topic will focus on novel methods and their applications on pediatric clinical pharmacology. Original research or review papers related to novel quantitative methods or the application of quantitative analysis on in vitro, non-clinical or clinical data to understand drug disposition and/or response in children are welcome, and will be considered for publication.
