Renal Clearance in Newborns and Infants: Predictive Performance of Population-Based Modeling for Drug Development.

Szczegóły
Abstrakt

Tytuł:: Renal Clearance in Newborns and Infants: Predictive Performance of Population-Based Modeling for Drug Development.
Autorzy:: Wang J; Office of Drug Evaluation IV, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
Kumar SS; Department of Pediatrics, Division of Clinical Pharmacology, University of Utah School of Medicine, Salt Lake City, Utah, USA.
Sherwin CM; Department of Pediatrics, Division of Clinical Pharmacology, University of Utah School of Medicine, Salt Lake City, Utah, USA.
Ward R; Department of Pediatrics, Division of Clinical Pharmacology, University of Utah School of Medicine, Salt Lake City, Utah, USA.
Baer G; Office of Pediatric Therapeutics, US Food and Drug Administration, Silver Spring, Maryland, USA.
Burckart GJ; Office of Clinical Pharmacology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
Wang Y; Office of Clinical Pharmacology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
Yao LP; Division of Pediatric and Maternal Health, Office of Drug Evaluation IV, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
Źródło:: Clinical pharmacology and therapeutics [Clin Pharmacol Ther] 2019 Jun; Vol. 105 (6), pp. 1462-1470. Date of Electronic Publication: 2019 Feb 10.
Typ publikacji:: Journal Article; Observational Study; Research Support, U.S. Gov't, P.H.S.
Język:: English
Imprint Name(s):: Publication: 2015- : Hoboken, NJ : Wiley
Original Publication: St. Louis : C.V. Mosby
MeSH Terms:: Models, Biological*
Drug Development/*methods
Glomerular Filtration Rate/*physiology
Metabolic Clearance Rate/*physiology
Amikacin/metabolism ; Amikacin/pharmacology ; Body Weight/drug effects ; Body Weight/physiology ; Drug Development/trends ; Female ; Forecasting ; Gestational Age ; Glomerular Filtration Rate/drug effects ; Heterocyclic Compounds/metabolism ; Heterocyclic Compounds/pharmacology ; Humans ; Infant ; Infant, Newborn ; Male ; Metabolic Clearance Rate/drug effects ; Organometallic Compounds/metabolism ; Organometallic Compounds/pharmacology ; Retrospective Studies ; Vancomycin/metabolism ; Vancomycin/pharmacology
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Grant Information:: FD999999 United States ImFDA Intramural FDA HHS
Substance Nomenclature:: 0 (Heterocyclic Compounds)
0 (Organometallic Compounds)
1BJ477IO2L (gadobutrol)
6Q205EH1VU (Vancomycin)
84319SGC3C (Amikacin)
99J2XUF1JT (gadolinium 1,4,7,10-tetraazacyclododecane-N,N',N'',N'''-tetraacetate)
Entry Date(s):: Date Created: 20181220 Date Completed: 20200304 Latest Revision: 20210109
Update Code:: 20240105
PubMed Central ID:: PMC6513721
DOI:: 10.1002/cpt.1332
PMID:: 30565653
: Czasopismo naukowe

The objective of this study was to evaluate the predictive performance of population models to predict renal clearance in newborns and infants. Pharmacokinetic (PK) data from eight drugs in 788 newborns and infants were used to evaluate the predictive performance of the population models based on postmenstrual age (PMA), postnatal age, gestational age, and body weight. For the PMA model, the average fold error for clearance (CL) predicted /CL observed was within a twofold range for each drug in all subgroups. For drugs with > 90% renal elimination, the prediction bias ranged from 0.7-1.3. For drugs with 60-80% renal elimination, the prediction bias ranged 0.6-2.0. Our results suggest that PMA-based sigmoidal maximum effect (E max ) model, in combination with bodyweight-based scaling and kidney function assessment, can be used in population PK (PopPK) modeling for drugs that are primarily eliminated via renal pathway to inform initial dose selection for newborns and infants with normal renal function in clinical trials.
(Published 2018. This article is a U.S. Government work and is in the public domain in the USA.)

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