Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Macimorelin in Children with Suspected Growth Hormone Deficiency: An Open-Label, Group Comparison, Dose-Escalation Trial.
Hormone research in paediatrics(2021)
Abstract
All 3 doses of macimorelin had excellent safety and tolerability with PK/PD profiles in expected ranges. These results support the use of 1.0 mg/mL macimorelin in a Phase 3 test validation trial in children.
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Key words
Drug safety,Drug tolerance,Growth hormone deficiency,Macimorelin,Paediatrics,Pharmacodynamics,Pharmacokinetics,Tolerability
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