4.The authorized considerations on the pre-clinical study of drug-eluting coronary stent system.
Maobo CHENG ; Xinli SHI ; Jianxiong JIA ; Jingjing MIAO ; Wei LIU ; Feilong NIE
Chinese Journal of Medical Instrumentation 2014;38(6):461-462
China Food and Drug Administration didn't issue any guideline on the pre-clinical study of drug-eluting coronary stent system, the basic requirement of the authorized administration was summarized to help manufacture prepare the document during the registration process.
China
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Drug Evaluation, Preclinical
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methods
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Drug-Eluting Stents
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Guidelines as Topic
8.Strategy of molecular drug design: hits, leads and drug candidates.
Acta Pharmaceutica Sinica 2008;43(9):898-904
Hits, leads and drug candidates constitute three millstones in the course of drug discovery and development. The definition of drug candidates is a critical point in the value chain of drug innovation, which not only differentiates the research and development stages, but more importantly, determines the perspective and destiny of the pre-clinical and clinical studies. All outcomes from the development stage are actually attributed to the chemical structure of candidates. The quality of candidates, however, is restricted by the drug-likeness of lead compounds, which in turn is decided by the characteristics of hits. The hit-to-lead is to provide a promising and druggable structure for further development, whereas the optimization of lead compounds is a process to transform an active compound into a drug, which in essence is molecular manipulation in multi-dimensional space related to pharmacodynamic, pharmacokinetic, physico-chemical, and safety properties. This review discusses the strategic principles in hit discovery, lead identification and optimization, as well as drug candidate definition with practical examples.
Animals
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Drug Design
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Drug Evaluation, Preclinical
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methods
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Drug Industry
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methods
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Humans
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Molecular Structure
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Pharmaceutical Preparations
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chemistry
9.Screening of active ingredients contained in natural products based on micro-fluidic chip technology.
Wenjuan LI ; Yi XU ; Qi FAN ; Kun CAO ; Qing ZHANG ; Changrui WANG ; Wei QIAN ; Xiaofeng ZHANG
China Journal of Chinese Materia Medica 2012;37(16):2492-2497
With the constant development of the drug screening technology, new screening methods and techniques have came to the fore, driving drug screening to grow rapidly and efficiently with a high throughput. Characterized by micro-scale analysis, high throughput, inheritability and good biocompatibility, the micro-fluidic analytical technology provides a new method and technical platform for screening active ingredients from natural products. This essay introduces multiple methods used for screening active ingredients from natural products and focuses on the micro-fluidic chip screening technology combined with cell culture and its characteristics, the composition of the platform of the micro-fluidic chip screening technology and its application in screening active ingredients from natural products.
Animals
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Biological Products
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chemistry
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Drug Evaluation, Preclinical
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methods
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Humans
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Microfluidic Analytical Techniques
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methods