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Therapie. 2018 Apr;73(2):165-170. doi: 10.1016/j.therap.2017.11.011. Epub 2018 Feb 16.

Principles and applications of pharmacometrics in drug evaluation in children.

Author information

1
Department of paediatric pharmacology and pharmacogenetics, Robert-Debré hospital, Assistance publique-Hôpitaux de Paris (AP-HP), 75019 Paris, France; Neonatology, CHU Rennes Sud, 35033 Rennes, France.
2
Department of paediatric pharmacology and pharmacogenetics, Robert-Debré hospital, Assistance publique-Hôpitaux de Paris (AP-HP), 75019 Paris, France.
3
University of Paris Diderot Sorbonne Paris Cité, 75013 Paris, France; Clinical pharmacy department, pharmaceutical sciences university, Shandong university, 266510 Shandong Sheng, China.
4
Department of paediatric pharmacology and pharmacogenetics, Robert-Debré hospital, Assistance publique-Hôpitaux de Paris (AP-HP), 75019 Paris, France; University of Paris Diderot Sorbonne Paris Cité, 75013 Paris, France; Clinical investigation center (CIC1426), Inserm, AP-HP, 75019 Paris, France. Electronic address: evelyne.jacqz-aigrain@aphp.fr.

Abstract

Drug evaluation in children is difficult for many well-identified reasons and many drugs are still used off-label. Innovative approaches are particularly adapted to the paediatric and neonatal populations, as clinical trials are difficult to conduct, need adapted designs in order to define the optimal dosage regimen in many diseases and therapeutic areas. Population approaches to define pharmacokinetics and pharmacokinetic/pharmacodynamics are now more currently used to define dosing regimens, adapted to the different paediatric and neonatal age groups, that allow to increase efficacy and reduce toxicity, by taking into account factors explaining variability in drug response. Such approaches are presented and the evaluation of vancomycin in neonates is detailed as different steps allowed validation of the optimal strategy to administer vancomycin in neonates.

KEYWORDS:

Child; Drug; Pharmacodynamics; Pharmacokinetics; Population modeling dosage adaptation; Vancomycin; Variability

PMID:
29605146
DOI:
10.1016/j.therap.2017.11.011
[Indexed for MEDLINE]

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