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首页> 外文期刊>Journal of the American Pharmaceutical Association: APhA >Understanding the scientific issues embedded in the generic drug approval process.
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Understanding the scientific issues embedded in the generic drug approval process.

机译：了解仿制药审批流程中嵌入的科学问题。

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OBJECTIVE: To review the major scientific issues embedded in the generic drug approval process. DATA SOURCES: Articles indexed initially under terms such as generic medications, generic drugs, bioequivalence, and bioinequivalence. These terms were used to search indexing services such as MEDLINE, International Pharmaceutical Abstracts, CINAHL (a database of nursing and allied health literature), and Science Citation Index. Additional data sources included the Code of Federal Regulations and regulatory guidances from the Food and Drug Administration (FDA) Center for Drug Evaluation and Research. STUDY SELECTION: Performed by the authors. DATA EXTRACTION: Not applicable. DATA SYNTHESIS: Despite the fact that regulations regarding bioequivalence have been in place for more than 20 years, controversies over bioequivalence continue to arise. Consensus on many of these issues is driving the development of new FDA guidances regarding bioequivalence. Still, despite the issuance of new guidance and consensus building among scientists, many clinicians and consumers remain uninformed regarding the scientific basis for establishing bioequivalence and the generic drug approval process in general. Although some have suggested that the generic drug approval process is flawed, overall, it appears that the process works. CONCLUSION: Understanding the generic drug approval process and the issues surrounding bioequivalence is of paramount importance to both clinicians and scientists.
机译：目的：审查仿制药批准过程中包含的主要科学问题。数据来源：最初以非专利药物，非专利药物，生物等效性和生物等效性等术语索引的文章。这些术语用于搜索索引服务，例如MEDLINE，International Pharmaceutical Abstracts，CINAHL（护理和相关健康文献数据库）和Science Citation Index。其他数据来源包括美国食品和药物管理局（FDA）药物评估和研究中心的《联邦法规》和法规指南。研究选择：由作者执行。数据提取：不适用。数据综合：尽管有关生物等效性的法规已经实施了20多年，但有关生物等效性的争议仍在继续。关于许多这些问题的共识正在推动有关生物等效性的FDA新指南的发展。尽管如此，尽管科学家发布了新的指南并建立了共识，但许多临床医生和消费者仍未获得有关建立生物等效性和通用药品批准程序的科学依据的信息。尽管有些人认为仿制药批准程序存在缺陷，但总的来说，该程序似乎有效。结论：了解通用药物批准过程和围绕生物等效性的问题对临床医生和科学家都至关重要。

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