Pediatric Age Groups and Approach to Studies.

developmental drug metabolism developmental renal function pediatric clinical trials pediatric pharmacology perinatal drug metabolism

Journal

Therapeutic innovation & regulatory science
ISSN: 2168-4804
Titre abrégé: Ther Innov Regul Sci
Pays: Switzerland
ID NLM: 101597411

Informations de publication

Date de publication:
09 2019
Historique:
pubmed: 18 7 2019
medline: 19 3 2020
entrez: 18 7 2019
Statut: ppublish

Résumé

Pediatric clinical trials are often requested according to specific age ranges. In the past and still today, these ages may correspond to developmental stages, such as newborn, infancy, childhood, and adolescence. Selection of ages for pediatric participation in medication studies should correspond to ages of rapid changes in pharmacokinetics and pharmacodynamics. Age-related changes in several enzymes involved in drug metabolism and glomerular filtration are described as examples of optimal ages for study of specific drugs according to their pathways of disposition.

Identifiants

pubmed: 31311309
doi: 10.1177/2168479019856572
doi:

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

584-589

Auteurs

Kathleen M Job (KM)

1 Division of Clinical Pharmacology, Department of Pediatrics, University of Utah, Salt Lake City, UT, USA.

Margaret Gamalo (M)

2 Global Statistical Sciences, Eli Lilly and Co, Indianapolis, IN, USA.

Robert M Ward (RM)

1 Division of Clinical Pharmacology, Department of Pediatrics, University of Utah, Salt Lake City, UT, USA.

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Classifications MeSH