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定量药理学的全球化:药物研发与监管中的首次定量药理国际研讨会

Globalization of quantitative pharmacology: first international symposium of quantitative pharmacology in drug development and regulation.

作者信息

Barrett Jeffrey S, Shi Jun, Xie Hai-Tang, Huang Xiao-Hui, Fossler Michael J, Sun Rui-Yuan

机构信息

Laboratory for Applied PK/PD, Clinical Pharmacology & Therapeutics Division, The Children's Hospital of Philadelphia, The University of Pennsylvania Medical School, Pediatrics Department, Abramson Research Center, Philadelphia, PA 19104, USA.

出版信息

J Clin Pharmacol. 2008 Jul;48(7):787-92. doi: 10.1177/0091270008319331. Epub 2008 May 19.

Abstract

The First International Symposium on Quantitative Pharmacology in Drug Development and Regulatory Sciences was held this past October in Nanjing, China, marking the first time scientists from around the globe gathered to discuss topics related to quantitative pharmacology in the Far East. With the recent trend toward global drug development and clinical trials in nontraditional countries, China has been regarded by many as the next frontier for the pharmaceutical industry. Quantitative pharmacology embraces all phases of pharmaceutical research and development, providing a mechanism to bridge decision making from one phase of development to the next, and it facilitates multidisciplinary partnerships through the assembly of both data and models that describe complex biological, biopharmaceutic, and clinical settings. Efforts in China are at an early stage, but it is clear that Chinese scientists embrace the discipline and are keen to promote this methodology in the registration of new drugs in China. While challenges exist, they represent an exciting area of future collaboration.

摘要

首届药物研发与监管科学定量药理学国际研讨会于去年10月在中国南京举行,这标志着全球科学家首次齐聚远东地区,共同探讨与定量药理学相关的话题。随着近期全球药物研发和在非传统国家开展临床试验的趋势,中国被许多人视为制药行业的下一个前沿阵地。定量药理学涵盖了药物研发的各个阶段,为连接从一个研发阶段到下一个阶段的决策提供了一种机制,并且通过汇集描述复杂生物学、生物药剂学和临床环境的数据和模型,促进了多学科合作。中国在这方面的努力尚处于早期阶段,但很明显,中国科学家接受这一学科,并热衷于在中国新药注册中推广这种方法。虽然存在挑战,但它们代表了一个令人兴奋的未来合作领域。

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