Black Triangle Drugs (▼) - An Outline

AP Ravinandan, Nagarathna Poojary
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Abstract

Each drugs undergoes clinical trial phase before introducing into pharmaceutical market. Generally clinical trials involve a small number of patients who take the medicine for a short period. During this phase, patients are carefully selected and followed up very closely under controlled conditions. These initial trials will report only more common adverse drug effects. But the rare and long latency adverse drug effects can be reported only when the medicine is consumed by a large population [1]. In a real-life setting, a larger and more diverse group of patients will take the medicines. They may have co-morbidities and they may be taking other concomitant medicines also. Some less common or rare side effects may only occur once a medicine has been used for a long time or duration by many people. It is therefore vital that the safety of all medicines continues to be monitored while they are in commercial use. Information is continuously collected after the medicine is placed on the market to monitor real-life experiences with the product. The Commission on Human Medicines (CHM) and Medicines and Healthcare products Regulatory Agency (MHRA) encourage the reporting of all suspected reactions to newly introduced medicines to the market.
黑三角毒品(▼)-提纲
每种药物在进入医药市场之前都要经过临床试验阶段。一般来说,临床试验涉及一小部分患者,他们在短时间内服用药物。在这一阶段,患者被精心挑选,并在受控条件下密切随访。这些初步试验将只报告更常见的药物不良反应。但罕见且潜伏期长的药物不良反应只有在大量人群使用时才能报道[1]。在现实生活中,更大、更多样化的患者群体将服用这些药物。他们可能有合并症,也可能同时服用其他药物。一些不太常见或罕见的副作用可能只有在许多人长期使用一种药物时才会出现。因此,至关重要的是,在所有药物用于商业用途时继续监测其安全性。药物投放市场后,信息不断收集,以监测产品的实际使用情况。人类药品委员会(CHM)和药品和保健产品监管机构(MHRA)鼓励报告所有对新上市药物的可疑反应。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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