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药物和生物制品的研发

Research and development of drugs and biologic entities.

作者信息

Piascik M M

机构信息

Division of Pharmacology and Experimental Therapeutics, University of Kentucky, Lexington 40536-0082.

出版信息

Am J Hosp Pharm. 1991 Oct;48(10 Suppl 1):S4-13.

PMID:1772113
Abstract

Uses of and problems associated with the products of biotechnology are described, and implications of the new technology for pharmacy practice and education are outlined. Biotechnology is the application of biological processes to the generation of new therapeutic and diagnostic drug products and vaccines. More than 100 biotechnology products are under development in the United States. Sixteen products, including 13 therapeutic agents and three vaccines, have been marketed. The largest category of biotechnology products now in development is monoclonal antibodies; nearly half of these are targeted for cancer therapy. The second largest group of agents undergoing clinical trials is vaccines. Showing particular promise are products such as colony-stimulating factors and growth factors, which may offer therapy for conditions that are currently untreatable. Problems intrinsic to the products of biotechnology include their short half-lives, difficulties associated with delivering the product in a timely fashion to a specific site, and, in the case of vaccines, the ability of the target organisms to change their structure. Ethical and economic considerations complicate decisions facing those concerned with the rational use of these products. Preparing pharmacy students and practitioners to take a lead role in the use of the products of biotechnology will require substantial modifications in pharmacy education and training at all levels. While some schools of pharmacy have instituted major curriculum revisions to accommodate such needs, others have yet to respond to the challenge of biotechnology. Biotechnology offers increasing opportunities for pharmacists to take an active role in therapeutic decision making, drug delivery, and the education of their health-care colleagues and of patients.

摘要

描述了生物技术产品的用途及相关问题,并概述了这项新技术对药学实践和教育的影响。生物技术是指将生物过程应用于生产新的治疗和诊断药品及疫苗。美国有100多种生物技术产品正在研发中。已有16种产品上市,包括13种治疗剂和3种疫苗。目前正在研发的最大类别的生物技术产品是单克隆抗体;其中近一半用于癌症治疗。正在进行临床试验的第二大类药物是疫苗。集落刺激因子和生长因子等产品显示出特别的前景,它们可能为目前无法治疗的病症提供治疗方法。生物技术产品固有的问题包括它们的半衰期短、难以及时将产品输送到特定部位,以及就疫苗而言,目标生物体改变其结构的能力。伦理和经济方面的考虑使那些关注合理使用这些产品的人所面临的决策变得复杂。要让药学专业的学生和从业者在生物技术产品的使用中发挥主导作用,就需要对各级药学教育和培训进行重大改革。虽然一些药学院已经对课程进行了重大修订以满足此类需求,但其他学院尚未应对生物技术带来的挑战。生物技术为药剂师在治疗决策、药物输送以及对医护同事和患者的教育中发挥积极作用提供了越来越多的机会。

相似文献

1
Research and development of drugs and biologic entities.药物和生物制品的研发
Am J Hosp Pharm. 1991 Oct;48(10 Suppl 1):S4-13.
2
Biotechnology products: new opportunities and responsibilities for the pharmacist.生物技术产品:药剂师面临的新机遇与责任
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3
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