Exposure‐Response Analysis of Vamorolone (VBP15) in Boys With Duchenne Muscular Dystrophy

Exposure‐response relationships of vamorolone, a novel dissociative steroidal anti‐inflammatory drug, were investigated in clinical trials in boys with Duchenne muscular dystrophy. Variables were clinical outcome measures, Fridericia‐corrected QT (QTcF) duration, and pharmacodynamic (PD) biomarkers....

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Veröffentlicht in:	Journal of clinical pharmacology 2020-10, Vol.60 (10), p.1385-1396
Hauptverfasser:	Li, Xiaonan, Conklin, Laurie S., den Anker, John, Hoffman, Eric P., Clemens, Paula R., Jusko, William J.
Format:	Artikel
Sprache:	eng
Schlagworte:	Administration, Oral Anti-Inflammatory Agents - administration & dosage Anti-Inflammatory Agents - adverse effects Anti-Inflammatory Agents - pharmacokinetics Anti-Inflammatory Agents - therapeutic use Area Under Curve Biomarkers Biomarkers - blood CD23 antigen Chemokines Child children Clinical trials Clinical Trials as Topic Dosage Dose-Response Relationship, Drug Drug Administration Schedule Duchenne muscular dystrophy (DMD) Duchenne's muscular dystrophy exposure‐response glucocorticoids Heart Conduction System - drug effects Humans Inflammation Insulin Lymphotoxin Macrophages Male Matrix metalloproteinase Metalloproteinase Muscular dystrophy Muscular Dystrophy, Duchenne - drug therapy Pharmacodynamics Pregnadienediols - administration & dosage Pregnadienediols - adverse effects Pregnadienediols - pharmacokinetics Pregnadienediols - therapeutic use Treatment Outcome vamorolone
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