Isaacs James T, Almeter Philip J, Henderson Bradley S, Hunter Aaron N, Platt Thomas L, Anwar Humza, Lodder Robert A
Department of Pharmacy Services, University of Kentucky, Lexington, KY 40536.
Pharmacy Practice & Sciences, College of Pharmacy, University of Kentucky, Lexington, KY 40506.
Contact Context. 2023;2023. doi: 10.6084/m9.figshare.21971213. Epub 2023 Jan 27.
Carfilzomib is a prescription injectable drug approved for use by the FDA as an antineoplastic agent, part of a drug class of medications known as proteasome inhibitors, and used to stop and slow the growth and progression of cancer cells within the body. The drug is approved as an agent to treat multiple myeloma. It is provided as a single-use vial that contains 60 mg of carfilzomib as a sterile, white to off-white lyophilized cake or powder. Intra-lot and inter-lot variability in the spectra of carfilzomib vials was detected in the Drug Quality Study (DQS) using Fourier transform near-infrared spectrometry (FTNIR). One of 12 vials of lot 1143966 manufactured for Onyx Pharmaceuticals, Inc. appeared 4.7 multidimensional standard deviations (SDs) from the other 11 vials in a 3-D space formed by the first 3 principal components, which captured 81% of the total spectral variation. Spectra of 168 vials from 18 lots in the spectral library formed two groups in the 3-D space formed by the first 3 principal components. One group contained 155 vials and the other group contained 13 vials. The 2 groups had different locations and scales using a subcluster detection test at .
卡非佐米是一种经美国食品药品监督管理局（FDA）批准的注射用处方药，作为一种抗肿瘤药物，属于蛋白酶体抑制剂类药物，用于阻止和减缓体内癌细胞的生长及扩散。该药物被批准用于治疗多发性骨髓瘤。它以一次性使用的小瓶形式提供，每瓶含有60毫克卡非佐米，为无菌的白色至灰白色冻干块状物或粉末。在药物质量研究（DQS）中，使用傅里叶变换近红外光谱法（FTNIR）检测到卡非佐米小瓶光谱存在批次内和批次间的变异性。为安进制药公司生产的1143966批次的12个小瓶中，有1个小瓶在由前3个主成分形成的三维空间中，与其他11个小瓶相比，出现了4.7个多维标准差（SDs），这3个主成分捕获了总光谱变异的81%。光谱库中来自18个批次的168个小瓶的光谱，在由前3个主成分形成的三维空间中形成了两组。一组包含155个小瓶，另一组包含13个小瓶。使用子聚类检测测试时，这两组具有不同的位置和尺度。
