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首页> 外文学位 >AN ANALYSIS OF DRUG REGULATORY AFFAIRS AND PHARMACEUTICAL RESEARCH AND DEVELOPMENT IN FRANCE, JAPAN AND THE UNITED STATES 1960-1980 (LAWS).
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AN ANALYSIS OF DRUG REGULATORY AFFAIRS AND PHARMACEUTICAL RESEARCH AND DEVELOPMENT IN FRANCE, JAPAN AND THE UNITED STATES 1960-1980 (LAWS).

机译：1960-1980年法国，日本和美国的药物管制情况和药物研发分析。

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摘要

The use of drug therapy as a first line treatment for human disease expanded significantly in the mid 1940's. Since that time, new drugs have had a profound effect upon morbidity and mortality. Drug therapy today is perhaps the most cost efficient approach to the treatment of human disease. Therefore, the availability of new drugs in any specific country can be expected to have a significant impact upon the quality and cost of health care.; Research concerning the number of new drug introductions in the United States since 1940 revealed a marked rise up to 1959, followed by a precipitous fall through 1978. Wardell and others have attributed the fall in new drug introductions in the United States to drug regulations. Their comparative studies have demonstrated greater numbers on new drug introductions in Europe than the United States as well as shorter drug approval times.; This study examined the drug regulatory environment and pharmaceutical research and development in France, Japan and the United States from 1960-1980 in an effort to determine if comparative regulatory environments in addition to other factors (such as economies of scale) have caused certain types of drug development studies to be carried out in other key industrialized countries rather than in the United States. This movement of research activities outside the United States would explain the earlier registration of drugs abroad as well as providing insight into the operations of multinational pharmaceutical companies.; The case study method was utilized in this analysis, due to the proprietary nature of information associated with the movement of new drugs by multinationals during research and development.; The findings of this analysis include: (1) the emergence of a geocentric approach by multinationals toward pharmaceutical research and development and drug regulatory affairs (2) the movement of early preclinical studies to France and Japan from the United States, due in great measure to comparative regulatory environments, economies of scale and the multinational geocentric approach to research and development.
机译：在1940年代中期，药物治疗作为人类疾病的一线治疗方法的使用大大增加。从那时起，新药对发病率和死亡率产生了深远的影响。如今，药物疗法可能是治疗人类疾病的最具成本效益的方法。因此，可以预期在任何特定国家都有新药的使用会对医疗保健的质量和成本产生重大影响。有关自1940年以来美国新药引进数量的研究表明，直到1959年，美国的新药引进量都显着增加，随后到1978年急剧下降。Wardell等人将美国新药引进量的减少归因于药品法规。他们的比较研究表明，与美国相比，欧洲新药引进的数量更多，药物批准的时间更短。这项研究研究了1960-1980年法国，日本和美国的药品监管环境和药物研发，目的是确定除其他因素（例如规模经济）以外的比较监管环境是否造成了某些类型的药物开发研究将在其他主要工业国家而不是美国进行。研究活动在美国以外的转移将解释国外药物的较早注册，并提供对跨国制药公司运作的见解。由于跨国公司在研发过程中与新药的流通有关的信息具有专有性，因此在本分析中采用了案例研究方法。分析的结果包括：（1）跨国公司对药物研发和药物监管事务采取地心方法的出现（2）早期临床前研究从美国转移到法国和日本，很大程度上是由于比较监管环境，规模经济和跨国地心研究开发方法。

著录项

  • 作者

    REICH, JACK WAYNE.;

  • 作者单位

    Temple University.;

  • 授予单位 Temple University.;
  • 学科 Health Sciences Pharmacy.
  • 学位 Ph.D.
  • 年度 1984
  • 页码 261 p.
  • 总页数 261
  • 原文格式 PDF
  • 正文语种 eng
  • 中图分类 药剂学;
  • 关键词

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