Model Informed Pediatric Development Applied to Bilastine: Ontogenic PK Model Development, Dose Selection for First Time in Children and PK Study Design

Purpose Bilastine is an H 1 antagonist whose pharmacokinetics (PK) and pharmacodynamics (PD) have been resolved in adults with a therapeutic oral dose of 20 mg/day. Bilastine has favorable characteristics for use in pediatrics but the PK/PD and the optimal dose in children had yet to be clinically e...

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Veröffentlicht in:	Pharmaceutical research 2017-12, Vol.34 (12), p.2720-2734
Hauptverfasser:	Vozmediano, Valvanera, Sologuren, Ander, Lukas, John C., Leal, Nerea, Rodriguez, Mónica
Format:	Artikel
Sprache:	eng
Schlagworte:	Analysis Biochemistry Biomedical and Life Sciences Biomedical Engineering and Bioengineering Biomedicine Children Computer simulation Design Health aspects Medical Law Pediatrics Pharmacodynamics Pharmacokinetics Pharmacology/Toxicology Pharmacy Plasma levels Prediction models Research Paper Simulation methods
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