获取途径

作者

Smits, Anne Annaert, Pieter Cavallaro, Giacomo De Cock, Pieter A. J. G. de Wildt, Saskia N. Kindblom, Jenny M. Lagler, Florian B. Moreno, Carmen Pokorna, Paula Schreuder, Michiel F. Standing, Joseph F. Turner, Mark A. Vitiello, Benedetto Zhao, Wei Weingberg, Annelie‐Martina Willmann, Raffaella van den Anker, John Allegaert, Karel

作者单位

Department of Development and Regeneration KU Leuven Leuven Belgium 2Neonatal intensive Care unit University Hospitals Leuven Leuven Belgium Intensive Care and Pediatric Surgery, Erasmus MC‐Sophia Children's Hospital Rotterdam the Netherlands 9Department of Pharmacology and Toxicology, Radboud Institute Health Sciences Radboud University Medical Center Nijmegen the Netherlands 10Pediatric Clinical Research Center, Queen Silvia Children's Hospital Sahlgrenska University Hospital Gothenburg Sweden 11Institute for Inherited Metabolic Diseases and Department of Pediatrics Paracelsus Medical University, Clinical Research Center Salzburg Salzburg Austria 12Institute of Psychiatry and Mental Health, Child and Adolescent Psychiatry Department, Hospital General Universitario Gregorio Marañón, School of Medicine Universidad Complutense, IiSGM, CIBERSAM Madrid Spain 13Department of Pharmacology, First Faculty of Medicine Charles University and General University Hospital in Prague Prague Czech Republic 14Department of Paediatrics and Inherited Metabolic Disorders, First Faculty of Medicine Charles University and General University Hospital in Prague Prague Czech Republic 15Department of Physiology and Pharmacology Karolinska Institutet and Karolinska University Hospital Stockholm Sweden 16Department of Pediatric Nephrology, Radboud University Medical Center Radboud Institute for Molecular Life Sciences, Amalia Children's Hospital Nijmegen the Netherlands 17 UCL Great Ormond Street Institute of Child Health London UK 18 Great Ormond Street Hospital for Children NHS Foundation Trust London UK 19Institute for Infection and Immunity, St George's University of London London UK 20Department of Women's and Children's Health, Institute of Life Course and Medical Sciences University of Liverpool, Liverpool Health Partners Liverpool UK 21Division of Child and Adolescent Neuropsychiatry, Department of Public Health and Pediatrics University of Torino Torino Italy 22Department of Clinical Pharmacy, Key Laboratory of Chemical Biology (Ministry of Education), School of Pharmaceutical Sciences, Cheeloo College of Medicine Shandong University China 23Department of Pharmacy The First Affiliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan Hospital Jinan China 24Clinical Research Centre The First Affiliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan Hospital Jinan China 25Department of Orthopedics and Traumatology Medical University of Graz Graz Austria 26Biozentrum University of Basel Basel Switzerland 27Paediatric Pharmacology and Pharmacometrics, University Children's Hospital Basel (UKBB) University of Basel Basel Switzerland 28 Division of Clinical Pharmacology, Children's National Hospital Washington DC USA 29 Department of Pharmaceutical and Pharmacological Sciences, KU Leuven Leuven Belgium 30Department of Hospital Pharmacy Erasmus MC University Medical Center Rotterdam the Netherlands Neonatal intensive care unit, Fondazione IRCCS Ca’ Grande Ospedale Maggiore Policlinico Milan Italy 5Department of Pediatric Intensive Care Ghent University Hospital Ghent Belgium 6Heymans Institute of Pharmacology Ghent University Ghent Belgium 7Department of Pharmacy Ghent University Hospital Ghent Belgium Drug Delivery and Disposition, Department of Pharmaceutical and Pharmacological Sciences, KU Leuven Leuven Belgium

刊名

British Journal of Clinical Pharmacology

年份

2022

卷号

Vol.88 No.12

页码

4965-4984

ISSN

0306-5251

关键词

developmental pharmacology drug development paediatrics

摘要

Developmental pharmacology describes the impact of maturation on drug disposition and drug effects throughout the paediatric age range. This paper, written by a multidisciplinary group of experts, summarizes current knowledge, and provides suggestions to pharmaceutical companies, regulatory agencies and academicians on how to incorporate the latest knowledge regarding developmental pharmacology and innovative techniques into neonatal and paediatric drug development. Biological aspects of drug ...更多

Developmental pharmacology describes the impact of maturation on drug disposition and drug effects throughout the paediatric age range. This paper, written by a multidisciplinary group of experts, summarizes current knowledge, and provides suggestions to pharmaceutical companies, regulatory agencies and academicians on how to incorporate the latest knowledge regarding developmental pharmacology and innovative techniques into neonatal and paediatric drug development. Biological aspects of drug absorption, distribution, metabolism and excretion throughout development are summarized. Although this area made enormous progress during the last two decades, remaining knowledge gaps were identified. Minimal risk and burden designs allow for optimally informative but minimally invasive PK sampling, while concomitant profiling of drug metabolites may provide additional insight in the unique PK behaviour in children. Furthermore, developmental PD needs to be considered during drug development, which is illustrated by disease‐ and/or target organ‐specific examples. Identifying and testing PD targets and effects in special populations, and application of age‐ and/or population‐specific assessment tools are discussed. Drug development plans also need to incorporate innovative techniques such as preclinical models to study therapeutic strategies, and shift from sequential enrolment of subgroups, to more rational designs. To stimulate appropriate research plans, illustrations of specific PK/PD‐related as well as drug safety‐related challenges during drug development are provided. The suggestions made in this joint paper of the Innovative Medicines Initiative conect4children Expert group on Developmental Pharmacology and the European Society for Developmental, Perinatal and Paediatric Pharmacology, should facilitate all those involved in drug development.收起

文献类型

期刊

浏览量

1