Wang Y, Booth B, Rahman A, Kim G, Huang S M, Zineh I
Office of Clinical Pharmacology, Office of Translational Sciences, US Food and Drug Administration, Silver Spring, Maryland, USA.
Office of Hematology and Oncology Products, Office of New Drugs, US Food and Drug Administration, Silver Spring, Maryland, USA.
Clin Pharmacol Ther. 2017 May;101(5):582-584. doi: 10.1002/cpt.628. Epub 2017 Mar 15.
There has been increased interest in optimizing dosing regimens for oncology products over the past decade. Investigations to refine dosing regimens often occur after new drug approval. There is growing focus on the use of exposure-response (ER) approaches to identify optimal dosing regimens for therapeutic biologics. Herein, we describe several recent observations that have informed our thinking on the use of ER analyses in the dose regimen optimization of therapeutic biologics developed to treat cancer.
在过去十年中，人们对优化肿瘤学产品给药方案的兴趣与日俱增。完善给药方案的研究通常在新药获批后进行。越来越多的关注点在于利用暴露-反应（ER）方法来确定治疗性生物制品的最佳给药方案。在此，我们描述了一些近期的观察结果，这些结果为我们在治疗癌症的治疗性生物制品剂量方案优化中使用ER分析的思考提供了依据。
