论文部分内容阅读
上市后监测为一种新药正式作为商品上市后的必要步骤。其基本目的是查明新药的短、中期影响,包括在临床试验中未被发现的及未预见的影响。 近十年来Norplant已逐渐在全世界广泛使用。虽然临床试验已证明使用NorpIant无严重不利的短期后果,但仍需要对潜在副反应进行监测。本课题为一次大规模、有组织的上市后监测,旨在判明大规模使用Norplant时是否存在在上市前少量临床试验中尚未发现的其他副反应,从而证实Norplant的短期及中长期的安全性。 Norplant上市后监测是由三个国际组织(国际家庭健康、人口理事会、世界卫生组织人类生殖处)
Post-market surveillance as a new drug officially listed as a necessary step after the product. Its basic purpose is to identify short and medium term effects of new drugs, including undetected and unforeseen effects in clinical trials. Norplant has been gradually used around the world for nearly a decade. Although clinical trials have shown no serious adverse short-term consequences of using NorpIant, potential adverse reactions still need to be monitored. This is a large-scale, organized postmarketing monitoring designed to determine whether Norplant has any other side effects that have not been identified in a small number of premarketing clinical trials to demonstrate Norplant’s short- and long-term safety profile. Norplant Post-Market Surveillance is conducted by three international organizations (International Family Health, Population Councils, World Health Organization Human Reproductive Services)