Claiming desmopressin therapeutic equivalence in children requires pediatric data: a population PKPD analysis.

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Abstract

For a new formulation of a drug, only pharmacokinetic bioequivalence with the original formulation has to be demonstrated in healthy, young adults. However, "children are not small adults," and to guarantee a safe and effective treatment, age-adapted drug development is required. Desmopressin, a vasopressin analogue prescribed for nocturnal enuresis in children, was studied as an example formulation first developed in adults and then extrapolated to a pediatric indication.

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Journal

Journal ID (iso-abbrev): Eur. J. Clin. Pharmacol.

Title: European journal of clinical pharmacology

Publisher: Springer Nature

ISSN (Electronic): 1432-1041

ISSN (Print): 0031-6970

Publication date (Electronic): Mar 2018

Volume: 74

Issue: 3

Affiliations

[1 ] Laboratory of Medical Biochemistry and Clinical Analysis, Department of Bioanalysis, Faculty of Pharmaceutical Sciences, Ghent University, Ottergemsesteenweg 460, 9000, Ghent, Belgium. robin.michelet@ugent.be.

[2 ] Department of Pediatric Nephrology, Ghent University Hospital, De Pintelaan 185, 9000, Ghent, Belgium. lien.dossche@ugent.be.

[3 ] Department of Pediatric Nephrology, Ghent University Hospital, De Pintelaan 185, 9000, Ghent, Belgium.

[4 ] Laboratory of Medical Biochemistry and Clinical Analysis, Department of Bioanalysis, Faculty of Pharmaceutical Sciences, Ghent University, Ottergemsesteenweg 460, 9000, Ghent, Belgium.

Article

Publisher Item ID: 10.1007/s00228-017-2386-0

DOI: 10.1007/s00228-017-2386-0

PubMed ID: 29198064

SO-VID: 3f0c4ee6-9b44-4f6a-a811-f1274a49cecb

History

Keywords: 1-Deamino-8-D-arginine vasopressin (dDAVP),Bioequivalence,Tablet,PKPD modeling,Lyophilisate,Children

Data availability:

Keywords: 1-Deamino-8-D-arginine vasopressin (dDAVP), Bioequivalence, Tablet, PKPD modeling, Lyophilisate, Children

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