首次儿科使用营销授权 : 案例研究。
关键词: Buccolam (midazolam oromucosal solution) Committee for Medicinal Products for Human Use European Medicines Agency Paediatric Use Marketing Authorisation centralized procedure efficacy epileptic seizure marketing authorization nonclinical pediatric investigation plan pediatric regulation pharmacodynamic pharmacokinetic quality safety
来 源:
DOI:10.1177/2168479014537260
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