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SHR Neuro Cancer Cardio Lipid Metab Microb

Smits, A; Annaert, P; Cavallaro, G; De, Cock, PAJG; de, Wildt, SN; Kindblom, JM; Lagler, FB; Moreno, C; Pokorna, P; Schreuder, MF; Standing, JF; Turner, MA; Vitiello, B; Zhao, W; Weingberg, AM; Willmann, R; van, den, Anker, J; Allegaert, K.
Current knowledge, challenges and innovations in developmental pharmacology: a combined c4c expert group and ESDPPP White paper.
Br J Clin Pharmacol. 2021; Doi: 10.1111/bcp.14958 [OPEN ACCESS]
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Co-authors Med Uni Graz: Weinberg Annelie-Martina
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Abstract:: 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 (ADME) 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 behavior 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 like preclinical models to study therapeutic strategies, and shift from sequential enrollment 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.
Find related publications in this database (Keywords): developmental pharmacology; drug development; paediatrics