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制药行业的全球化:医生在评估药物安全性中的作用。

Globalization of the pharmaceutical industry: the physician's role in evaluating drug safety.

作者信息

Beg M M

机构信息

Department of Clinical Research and Development, Wyeth-Ayerst Laboratories, Philadelphia, Pennsylvania 19101.

出版信息

J Clin Pharmacol. 1990 Nov;30(11):994-6. doi: 10.1002/j.1552-4604.1990.tb03584.x.

DOI:10.1002/j.1552-4604.1990.tb03584.x
PMID:2243157
Abstract

The trend toward uniformity of drug registration procedures due to imminent European Economic Community globalization has encouraged pharmaceutical companies to conduct studies on a worldwide basis. This standardization of methods will facilitate the "poolability" of efficacy and safety data generated by these international studies into a common database. With the internationalization of the pharmaceutical marketplace, physicians in industry may be required to collect and interpret such reports from all over the globe. The globalization of the pharmaceutical industry will thus broaden the opportunities for physician involvement in safety detection.

摘要

由于欧洲经济共同体即将实现全球化,药品注册程序趋于统一,这鼓励了制药公司在全球范围内开展研究。方法的标准化将有助于把这些国际研究产生的疗效和安全性数据“汇集”到一个通用数据库中。随着制药市场的国际化,业内医生可能需要收集和解读来自全球各地的此类报告。因此,制药行业的全球化将为医生参与安全检测带来更多机会。

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