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Koselugo (selumetinib)
申请企业
ASTRAZENECA PHARMACEUTICALS LP
药品名称
Koselugo (selumetinib)
承诺描述
Submit the final report and datasets from a pharmacokinetic trial in pediatric patients to confirm the effect of a low-fat meal on selumetinib exposure with the marketed capsule formulation and evaluate whether administration of selumetinib with food may alleviate gastrointestinal toxicities. Confirm appropriate dosing recommendation of selumetinib with a low-fat meal that maintains efficacy with acceptable safety.