化疗药物复方制剂用量的评估:九家复方药房之间的比较。

IF 2.3 2区 农林科学 Q1 VETERINARY SCIENCES Veterinary and comparative oncology Pub Date : 2024-12-01 Epub Date: 2024-08-20 DOI:10.1111/vco.13003
Samantha R Bajorek, Trina N Hazzah, John D Chretin, Tracy N Mills, Talon S McKee, Jennifer R Frank, Jessica L Benvin-Guzzo, Kary A Clifton, Philip J Bergman
{"title":"化疗药物复方制剂用量的评估:九家复方药房之间的比较。","authors":"Samantha R Bajorek, Trina N Hazzah, John D Chretin, Tracy N Mills, Talon S McKee, Jennifer R Frank, Jessica L Benvin-Guzzo, Kary A Clifton, Philip J Bergman","doi":"10.1111/vco.13003","DOIUrl":null,"url":null,"abstract":"<p><p>The use of compounded formulations of chemotherapy in veterinary medicine is common. The purpose of this study was to evaluate the drug amount of two compounded chemotherapeutics (chlorambucil and cyclophosphamide) from multiple veterinary compounding pharmacies, to determine if there was a difference in drug amounts between those that came from 503A versus 503B pharmacies, and finally to determine heterogeneity in drug amounts within each individual pharmacy. Nine veterinary compounding pharmacies (eight 503A, one 503B) were sampled in total, with two different batches sampled from each pharmacy. Each capsule's actual concentration was compared to the intended (prescribed) concentration. Of the 68 total samples obtained, 20 (29%) tested outside the FDA-acceptable discrepancy of ±10%. Of these, 12 (60%) were chlorambucil and 8 (40%) were cyclophosphamide. 503A cyclophosphamide samples had an average discrepancy of 6.6% from the intended dose while samples from the 503B pharmacy had a discrepancy of 1.8%. 503A chlorambucil samples had an average discrepancy of 10.4% from the intended dose while samples from the 503B pharmacy had a discrepancy of 9.6%. Heterogeneity within the same pharmacy and batch ranged from 0.1% to 51% for the 503A pharmacies and 2.6% to 7.5% for the 503B pharmacy. Heterogeneity between different batches within the same pharmacy ranged from 0.4% to 58.3% for the 503A pharmacies and 5% to 14.8% for the 503B pharmacy. Although the drug amounts of compounded cyclophosphamide and chlorambucil manufactured by the 503B compounding pharmacy was more reliably maintained compared to that compounded by the 503A pharmacies, there was ultimately still potential for variability in drug amounts regardless of the pharmacy designation.</p>","PeriodicalId":23693,"journal":{"name":"Veterinary and comparative oncology","volume":" ","pages":"536-541"},"PeriodicalIF":2.3000,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Evaluation of the Amount of Compounded Chemotherapy Drugs: A Comparison Between Nine Compounding Pharmacies.\",\"authors\":\"Samantha R Bajorek, Trina N Hazzah, John D Chretin, Tracy N Mills, Talon S McKee, Jennifer R Frank, Jessica L Benvin-Guzzo, Kary A Clifton, Philip J Bergman\",\"doi\":\"10.1111/vco.13003\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><p>The use of compounded formulations of chemotherapy in veterinary medicine is common. The purpose of this study was to evaluate the drug amount of two compounded chemotherapeutics (chlorambucil and cyclophosphamide) from multiple veterinary compounding pharmacies, to determine if there was a difference in drug amounts between those that came from 503A versus 503B pharmacies, and finally to determine heterogeneity in drug amounts within each individual pharmacy. Nine veterinary compounding pharmacies (eight 503A, one 503B) were sampled in total, with two different batches sampled from each pharmacy. Each capsule's actual concentration was compared to the intended (prescribed) concentration. Of the 68 total samples obtained, 20 (29%) tested outside the FDA-acceptable discrepancy of ±10%. Of these, 12 (60%) were chlorambucil and 8 (40%) were cyclophosphamide. 503A cyclophosphamide samples had an average discrepancy of 6.6% from the intended dose while samples from the 503B pharmacy had a discrepancy of 1.8%. 503A chlorambucil samples had an average discrepancy of 10.4% from the intended dose while samples from the 503B pharmacy had a discrepancy of 9.6%. Heterogeneity within the same pharmacy and batch ranged from 0.1% to 51% for the 503A pharmacies and 2.6% to 7.5% for the 503B pharmacy. Heterogeneity between different batches within the same pharmacy ranged from 0.4% to 58.3% for the 503A pharmacies and 5% to 14.8% for the 503B pharmacy. Although the drug amounts of compounded cyclophosphamide and chlorambucil manufactured by the 503B compounding pharmacy was more reliably maintained compared to that compounded by the 503A pharmacies, there was ultimately still potential for variability in drug amounts regardless of the pharmacy designation.</p>\",\"PeriodicalId\":23693,\"journal\":{\"name\":\"Veterinary and comparative oncology\",\"volume\":\" \",\"pages\":\"536-541\"},\"PeriodicalIF\":2.3000,\"publicationDate\":\"2024-12-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Veterinary and comparative oncology\",\"FirstCategoryId\":\"97\",\"ListUrlMain\":\"https://doi.org/10.1111/vco.13003\",\"RegionNum\":2,\"RegionCategory\":\"农林科学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2024/8/20 0:00:00\",\"PubModel\":\"Epub\",\"JCR\":\"Q1\",\"JCRName\":\"VETERINARY SCIENCES\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Veterinary and comparative oncology","FirstCategoryId":"97","ListUrlMain":"https://doi.org/10.1111/vco.13003","RegionNum":2,"RegionCategory":"农林科学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2024/8/20 0:00:00","PubModel":"Epub","JCR":"Q1","JCRName":"VETERINARY SCIENCES","Score":null,"Total":0}
引用次数: 0

摘要

在兽医领域使用复方化疗制剂很常见。本研究的目的是评估来自多家兽用复方制剂药房的两种复方化疗药(氯霉素和环磷酰胺)的药量,确定来自503A和503B药房的药量是否存在差异,最后确定每个药房内药量的异质性。共抽查了九家兽药合成药房(八家 503A,一家 503B),每家药房抽查了两个不同批次的样品。每个胶囊的实际浓度都与预定(处方)浓度进行了比较。在总共获得的 68 个样本中,有 20 个样本(29%)的检测结果超出了美国食品及药物管理局可接受的 ±10% 的误差范围。其中 12 个(60%)是氯霉素,8 个(40%)是环磷酰胺。503A 环磷酰胺样本与预定剂量的平均偏差为 6.6%,而 503B 药房的样本偏差为 1.8%。503A 氯霉素样本与预定剂量的平均差异为 10.4%,而 503B 药房的样本与预定剂量的差异为 9.6%。在同一药房和同一批次中,503A 药房的异质性在 0.1% 至 51% 之间,503B 药房的异质性在 2.6% 至 7.5% 之间。同一药房不同批次药品之间的异质性,503A 药房为 0.4%至 58.3%,503B 药房为 5%至 14.8%。尽管与 503A 药房相比,503B 复方药房生产的复方环磷酰胺和氯丁氨嘧啶的药量更可靠,但无论药房名称如何,药量最终仍有可能出现差异。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
查看原文
分享 分享
微信好友 朋友圈 QQ好友 复制链接
本刊更多论文
Evaluation of the Amount of Compounded Chemotherapy Drugs: A Comparison Between Nine Compounding Pharmacies.

The use of compounded formulations of chemotherapy in veterinary medicine is common. The purpose of this study was to evaluate the drug amount of two compounded chemotherapeutics (chlorambucil and cyclophosphamide) from multiple veterinary compounding pharmacies, to determine if there was a difference in drug amounts between those that came from 503A versus 503B pharmacies, and finally to determine heterogeneity in drug amounts within each individual pharmacy. Nine veterinary compounding pharmacies (eight 503A, one 503B) were sampled in total, with two different batches sampled from each pharmacy. Each capsule's actual concentration was compared to the intended (prescribed) concentration. Of the 68 total samples obtained, 20 (29%) tested outside the FDA-acceptable discrepancy of ±10%. Of these, 12 (60%) were chlorambucil and 8 (40%) were cyclophosphamide. 503A cyclophosphamide samples had an average discrepancy of 6.6% from the intended dose while samples from the 503B pharmacy had a discrepancy of 1.8%. 503A chlorambucil samples had an average discrepancy of 10.4% from the intended dose while samples from the 503B pharmacy had a discrepancy of 9.6%. Heterogeneity within the same pharmacy and batch ranged from 0.1% to 51% for the 503A pharmacies and 2.6% to 7.5% for the 503B pharmacy. Heterogeneity between different batches within the same pharmacy ranged from 0.4% to 58.3% for the 503A pharmacies and 5% to 14.8% for the 503B pharmacy. Although the drug amounts of compounded cyclophosphamide and chlorambucil manufactured by the 503B compounding pharmacy was more reliably maintained compared to that compounded by the 503A pharmacies, there was ultimately still potential for variability in drug amounts regardless of the pharmacy designation.

求助全文
通过发布文献求助,成功后即可免费获取论文全文。 去求助
来源期刊
Veterinary and comparative oncology
Veterinary and comparative oncology 农林科学-兽医学
CiteScore
4.80
自引率
9.50%
发文量
75
审稿时长
>24 weeks
期刊介绍: Veterinary and Comparative Oncology (VCO) is an international, peer-reviewed journal integrating clinical and scientific information from a variety of related disciplines and from worldwide sources for all veterinary oncologists and cancer researchers concerned with aetiology, diagnosis and clinical course of cancer in domestic animals and its prevention. With the ultimate aim of diminishing suffering from cancer, the journal supports the transfer of knowledge in all aspects of veterinary oncology, from the application of new laboratory technology to cancer prevention, early detection, diagnosis and therapy. In addition to original articles, the journal publishes solicited editorials, review articles, commentary, correspondence and abstracts from the published literature. Accordingly, studies describing laboratory work performed exclusively in purpose-bred domestic animals (e.g. dogs, cats, horses) will not be considered.
期刊最新文献
Blood Neutrophil-to-Lymphocyte Ratio as a Potential Prognostic Marker in Dogs ≤10 kg With Multicentric Lymphoma. Incorporation of Biologic Variables Into the Staging for Canine Cutaneous and Subcutaneous Mast Cell Tumours: Proposal of the UBo pTNM System. Overactivation of Signal Transducer and Activator of Transcription 3 in Canine Hepatocellular Carcinoma and Its Prognostic Significance. Evaluation of the Amount of Compounded Chemotherapy Drugs: A Comparison Between Nine Compounding Pharmacies. Macrophage Colony Stimulating Factor (M-CSF) and Interleukin-34 (IL-34) Expression in Canine Osteosarcoma in the Context of the Tumour Immune Microenvironment.
×
引用
GB/T 7714-2015
复制
MLA
复制
APA
复制
导出至
BibTeX EndNote RefMan NoteFirst NoteExpress
×
×
提示
您的信息不完整,为了账户安全,请先补充。
现在去补充
×
提示
您因"违规操作"
具体请查看互助需知
我知道了
×
提示
现在去查看 取消
×
提示
确定
0
微信
客服QQ
Book学术公众号 扫码关注我们
反馈
×
意见反馈
请填写您的意见或建议
请填写您的手机或邮箱
已复制链接
已复制链接
快去分享给好友吧!
我知道了
×
扫码分享
扫码分享
Book学术官方微信
Book学术文献互助
Book学术文献互助群
群 号:481959085
Book学术
文献互助 智能选刊 最新文献 互助须知 联系我们:info@booksci.cn
Book学术提供免费学术资源搜索服务,方便国内外学者检索中英文文献。致力于提供最便捷和优质的服务体验。
Copyright © 2023 Book学术 All rights reserved.
ghs 京公网安备 11010802042870号 京ICP备2023020795号-1