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作者

Smits, Anne Annaert, Pieter Cavallaro, Giacomo De Cock, Pieter A. J. G 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 Anker, John Allegaert, Karel

作者单位

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

刊名

British Journal of Clinical Pharmacology

年份

2021

页码

1

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 a...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

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