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Pharmacometric Modeling of Naloxegol Efficacy and Safety: Impact on Dose and Label
Author(s) -
AlHuniti N,
Zhou D,
Xu H,
Aksenov S,
Bui KH,
Fox R,
Helmlinger G,
Stanski D
Publication year - 2017
Publication title -
clinical pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.941
H-Index - 188
eISSN - 1532-6535
pISSN - 0009-9236
DOI - 10.1002/cpt.719
Subject(s) - medicine , tolerability , opioid , pharmacology , adverse effect , receptor
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.