The pharmaceutical industry has an obligation to identify adverse reactions to drug products during all phases of drug development, including the post-marketing period. Estimates of population exposure to pharmaceutical products are important to the post-marketing surveillance of drugs, and provide a context for assessing the various risks and benefits, including drug safety, associated with drug treatment. This paper describes a systematic approach to estimating post-marketing drug exposure using ex-factory shipment data to estimate the quantity of medication available, and dosage information (stratified by indication or other factors as appropriate) to convert the quantity of medication to person time of exposure. Unlike the non-standardized methods often used to estimate exposure, this approach provides estimates whose calculations are explicit, documented, and consistent across products and over time. The methods can readily be carried out by an individual or small group specializing in this function, and lend themselves to automation. The present estimation approach is practical and relatively uncomplicated to implement. We believe it is a useful innovation.

译文

制药行业有义务在药物开发的所有阶段,包括上市后阶段,确定对药物产品的不良反应。估计人群对药品的暴露量对于药物上市后的监测很重要,并为评估与药物治疗相关的各种风险和收益 (包括药物安全性) 提供了背景。本文介绍了一种系统的方法来估计上市后的药物暴露,使用出厂装运数据来估计可用的药物数量,并使用剂量信息 (根据适应症或其他适当因素进行分层) 将药物数量转换为人的暴露时间。与通常用于估计暴露量的非标准化方法不同,这种方法提供的估算值是明确的,有文档记录的,并且在产品之间以及随着时间的推移是一致的。这些方法可以由专门从事此功能的个人或小组轻松执行,并有助于自动化。当前的估算方法是实用的,并且实施起来相对简单。我们认为这是一项有益的创新。

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