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抗糖尿病药物复方制剂研发的几点考虑

Considerations on research and development of fixed combination anti-diabetic medicinal products
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摘要 联合治疗是糖尿病患者控制血糖达标必不可少的重要手段,抗糖尿病药物复方制剂的研发,不是简单的将两种作用机制不同、用于糖尿病的药物组合在一起,而是需要以临床需求、临床实践以及可靠和稳健的临床试验结果为基础。为此本文提出了现阶段研发抗糖尿病药物复方制剂的原则和建议。 Combination therapy with different anti -diabetic medicinal products is indispensable to reach good blood glucose goals, fixed combination anti - diabetic medicinal products provide a new way to this aim nowadays. Fixed combination antidiabetic medicinal products have many advantages in clinical practice, however, they also have some limitations. Fixed combination medicinal products are not made up by two or more kinds of anti - diabetic medicinal products simply, they should be based on clinical demand, clinical practice, reasonable and stable clinical trial results. This article is intended to introduce principle and suggestions on research and development of fixed combination anti -diabetic medicinal products for drug finn while developing new medicinal products.
出处 《中国临床药理学杂志》 CAS CSCD 北大核心 2013年第1期76-77,共2页 The Chinese Journal of Clinical Pharmacology
关键词 抗糖尿病药物 复方制剂 anti -diabetic medicinal products fixed combination medicinal products
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  • 5EMA. Guideline on clinical Development of Fixed Combination Me- dicinal Products. http ://118. 26. 57. 16 : 82/ IQ2W3FAR5T6Y7U819OOP1Z2X3C4V5B/www. ema. europa, eu/ docs/en _ GB/document _ library/Scientific _ guideline/2009/09/ WC500003686. pdf, 2009 -02 - 19.

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