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Current knowledge, challenges and innovations in developmental pharmacology: A combined conect4children Expert Group and European Society for Developmental, Perinatal and Paediatric Pharmacology White Paper
A. Smits, P. Annaert, G. Cavallaro, PAJG. De Cock, SN. de Wildt, JM. Kindblom, FB. Lagler, C. Moreno, P. Pokorna, MF. Schreuder, JF. Standing, MA. Turner, B. Vitiello, W. Zhao, AM. Weingberg, R. Willmann, J. van den Anker, K. Allegaert
Jazyk angličtina Země Anglie, Velká Británie
Typ dokumentu časopisecké články, přehledy, práce podpořená grantem
NLK
Europe PubMed Central
od 1974 do Před 1 rokem
Wiley Free Content
od 1997 do Před 1 rokem
PubMed
34180088
DOI
10.1111/bcp.14958
Knihovny.cz E-zdroje
- MeSH
- biologické modely * MeSH
- dítě MeSH
- farmakokinetika MeSH
- farmakologie * MeSH
- lidé MeSH
- novorozenec MeSH
- sběr dat MeSH
- výzkumný projekt MeSH
- Check Tag
- dítě MeSH
- lidé MeSH
- novorozenec MeSH
- Publikační typ
- časopisecké články MeSH
- práce podpořená grantem MeSH
- přehledy MeSH
Developmental pharmacology describes the impact of maturation on drug disposition (pharmacokinetics, PK) and drug effects (pharmacodynamics, PD) 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.
Biozentrum University of Basel Basel Switzerland
Department of Development and Regeneration KU Leuven Leuven Belgium
Department of Hospital Pharmacy Erasmus MC University Medical Center Rotterdam the Netherlands
Department of Orthopedics and Traumatology Medical University of Graz Graz Austria
Department of Pediatric Intensive Care Ghent University Hospital Ghent Belgium
Department of Pharmaceutical and Pharmacological Sciences KU Leuven Leuven Belgium
Department of Pharmacy Ghent University Hospital Ghent Belgium
Division of Clinical Pharmacology Children's National Hospital Washington DC USA
Great Ormond Street Hospital for Children NHS Foundation Trust London UK
Heymans Institute of Pharmacology Ghent University Ghent Belgium
Institute for Infection and Immunity St George's University of London London UK
Intensive Care and Pediatric Surgery Erasmus MC Sophia Children's Hospital Rotterdam the Netherlands
Neonatal intensive care unit Fondazione IRCCS Ca' Grande Ospedale Maggiore Policlinico Milan Italy
Neonatal intensive Care unit University Hospitals Leuven Leuven Belgium
Citace poskytuje Crossref.org
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