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Regulatory hot topics: eight challenges

机译:监管热点:八项挑战

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摘要

From biotechnology to novel delivery systems, the ever-increasing complexity of new drugs provides major technical challenges for the pharmaceutical analyst. In this symposium, eight speakers from the pharmaceutical industry and from regulatory bodies in the United Kingdom (Medicines Control Agency) and the United States (Food and Drug Administration) identified and discussed key areas where analytical science continues to shape and be shaped by new regulations for registration of new drug preparations.
机译:从生物技术到新颖的递送系统,新药的日益复杂性为药物分析师带来了重大的技术挑战。在本次研讨会上,来自英国(药物控制局)和美国(食品和药物管理局)制药行业以及监管机构的八位发言人确定并讨论了分析科学继续发展并受新法规影响的关键领域用于新药制剂的注册。

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