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随着现代科学技术尤其是有机化学的发展,已涌现出数以千计的新合成药及老药的衍生物,临床医生面对这种“药品爆炸(drug explosion)”的局面,迫切要求了解哪些新药确实安全、有效、优质、价廉且优于老药值得临床应用,这就需要对新药进行正确评价包括临床前及临床研究。在美国,一个新药要经过反复临床研究验证才能批准上市。我国为了加强对药品的监督和管理,1985年7月也颁布了“药品管理
With the development of modern science and technology, especially organic chemistry, thousands of derivatives of new synthetic drugs and old drugs have emerged. Clinicians are faced with this kind of “drug explosion” and urgently need to understand Which new drugs are indeed safe, effective, high quality, low cost and superior to the old drug worthy of clinical application, which requires the correct evaluation of new drugs, including pre-clinical and clinical studies. In the United States, a new drug to go through repeated clinical studies to verify the listing. In order to strengthen the supervision and management of pharmaceuticals in our country, the “Drug Administration” was promulgated in July 1985