Vaibhav Kumar1, Fenggong Wang2, Meng Hu2

  • 1Division of Oncology 3, Office of Oncologic Diseases, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA.

概括

与心血管药物相比,通用瘤药物面临更长的开发时间表. 影响仿制药可用性的关键因素包括药物的复杂性和监管要求,例如为生物等价性研究注册患者.

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