监管科学作为连接科学与社会的桥梁。
Regulatory science as a bridge between science and society.
机构信息
Pharmaceuticals and Medical Devices Agency, Tokyo, Japan.
出版信息
Clin Pharmacol Ther. 2011 Jul;90(1):29-31. doi: 10.1038/clpt.2011.89.
PMID:21691273
Abstract
Development of innovative drugs has recently become more difficult. The case of rosiglitazone shows the extreme difficulty of making the regulatory decision that will best balance the benefits and risks of a drug. There is a high expectation that regulatory science (RS) can improve the situation. However, without user understanding of its basic characteristics, RS will not deliver what is expected.
摘要
新药研发最近变得愈发困难。罗格列酮案例表明，制定既能最大程度平衡药物获益与风险，又能符合监管要求的决策极具挑战性。人们高度期望监管科学（RS）能够改善这一现状。然而，如果使用者不了解 RS 的基本特征，那么 RS 也无法达到预期效果。
Zotero 插件