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  • Smits, Anne (author)

Current knowledge, challenges and innovations in developmental pharmacology: A combined conect4children Expert Group and European Society for Developmental, Perinatal and Paediatric Pharmacology White Paper.

  • Article/chapterEnglish2021

Publisher, publication year, extent ...

  • 2021-07-23
  • Wiley,2021

Numbers

  • LIBRIS-ID:oai:gup.ub.gu.se/311990
  • https://gup.ub.gu.se/publication/311990URI
  • https://doi.org/10.1111/bcp.14958DOI
  • http://kipublications.ki.se/Default.aspx?queryparsed=id:147133269URI

Supplementary language notes

  • Language:English

Part of subdatabase

Classification

  • Subject category:ref swepub-contenttype
  • Subject category:art swepub-publicationtype

Notes

  • gratis
  • 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.

Subject headings and genre

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  • Annaert, Pieter (author)
  • Cavallaro, Giacomo (author)
  • De Cock, Pieter A J G (author)
  • de Wildt, Saskia N (author)
  • Kindblom, Jenny,1971Gothenburg University,Göteborgs universitet,Institutionen för medicin, avdelningen för invärtesmedicin och klinisk nutrition,Centre for Bone and Arthritis Research,Institute of Medicine, Department of Internal Medicine and Clinical Nutrition(Swepub:gu)xkinje (author)
  • Lagler, Florian B (author)
  • Moreno, Carmen (author)
  • Pokorna, Paula (author)
  • Schreuder, Michiel F (author)
  • Standing, Joseph F (author)
  • Turner, Mark A (author)
  • Vitiello, Benedetto (author)
  • Zhao, Wei (author)
  • Weingberg, Annelie-Martina (author)
  • Willmann, Raffaella (author)
  • van den Anker, John (author)
  • Allegaert, Karel (author)
  • Göteborgs universitetInstitutionen för medicin, avdelningen för invärtesmedicin och klinisk nutrition (creator_code:org_t)
  • Göteborgs universitet
  • Gothenburg University
  • Göteborgs universitet
  • Gothenburg University

Related titles

  • In:British journal of clinical pharmacology: Wiley88:12, s. 4965-841365-21250306-5251

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