Pharmacometric Modeling of Naloxegol Efficacy and Safety: Impact on Dose and Label.

Al-Huniti, N; Zhou, D; Xu, H; Aksenov, S; Bui, K H; Fox, R; Helmlinger, G; Stanski, D

Al-Huniti, N; Zhou, D; Xu, H; Aksenov, S; Bui, K H; Fox, R; Helmlinger, G; Stanski, D.

Affiliation

Al-Huniti N; Quantitative Clinical Pharmacology, AstraZeneca LP, Waltham, Massachusetts, USA.
Zhou D; Quantitative Clinical Pharmacology, AstraZeneca LP, Waltham, Massachusetts, USA.
Xu H; Quantitative Clinical Pharmacology, AstraZeneca LP, Waltham, Massachusetts, USA.
Aksenov S; Quantitative Clinical Pharmacology, AstraZeneca LP, Waltham, Massachusetts, USA.
Bui KH; Quantitative Clinical Pharmacology, AstraZeneca LP, Waltham, Massachusetts, USA.
Fox R; Quantitative Clinical Pharmacology, AstraZeneca LP, Waltham, Massachusetts, USA.
Helmlinger G; Quantitative Clinical Pharmacology, AstraZeneca LP, Waltham, Massachusetts, USA.
Stanski D; Quantitative Clinical Pharmacology, AstraZeneca LP, Waltham, Massachusetts, USA.

Clin Pharmacol Ther ; 102(5): 741-744, 2017 Nov.

Article de En | MEDLINE | ID: mdl-28548207

ABSTRACT

ABSTRACT

Naloxegol is a peripherally acting µ-opioid receptor antagonist that was developed for the treatment of opioid-induced constipation. Modeling and simulation of naloxegol efficacy and tolerability informed selection of doses for phase III studies and provided comprehensive dosage recommendations for the naloxegol US package insert.

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Texte intégral: 1 Collection: 01-internacional Base de données: MEDLINE Sujet principal: Polyéthylène glycols / Étiquetage de médicament / Modèles biologiques / Morphinanes / Antagonistes narcotiques Type d'étude: Guideline / Prognostic_studies Limites: Animals / Humans Langue: En Journal: Clin Pharmacol Ther Année: 2017 Type de document: Article Pays d'affiliation: États-Unis d'Amérique

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