Regulatory Considerations for Contribution of Effect of Drugs Used in Combination Regimens: Renal Cell Cancer Case Studies

The development and review of combination drug regimens in oncology may present unique challenges to investigators and regulators. For regulatory approval of combination regimens, it is necessary to demonstrate the contribution of effect of each monotherapy to the overall combination. Alternative ap...

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Veröffentlicht in:	Clinical cancer research 2020-12, Vol.26 (24), p.6406-6411
Hauptverfasser:	Brewer, Jamie R, Chang, Elaine, Agrawal, Sundeep, Singh, Harpreet, Suzman, Daniel L, Xu, James, Weinstock, Chana, Fernandes, Laura L, Cheng, Joyce, Zhang, Lijun, Xie, Diqiong, Goldberg, Kirsten B, Bloomquist, Erik W, Tang, Shenghui, Sridhara, Rajeshwari, Theoret, Marc R, Pazdur, Richard, Ibrahim, Amna, Beaver, Julia A
Format:	Artikel
Sprache:	eng
Online-Zugang:	Volltext
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