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Highlights from a recent BIO survey on therapeutic protein - Drug interactions

机译:最近BIO关于治疗性蛋白质-药物相互作用的调查的重点

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Therapeutic proteins (TPs, protein macromole-cules with molecular weights in excess of 1 kDa) are becoming increasingly important as therapeutic agents. A number of them have become the standard of care in several therapeutic areas, such as immunology and oncology. It is anticipated that these agents will continue to play an important role in the future as the investment and efforts into the discovery and development of biologies continue to increase. By the existing regulatory guidance, virtually every small molecule drug development program includes an evaluation of the potential drug-drug interactions (DDIs) for concomitant medications. The scientific and regulatory framework of DDI studies for small molecule drugs is well developed and has been applied for many years.
机译:治疗性蛋白质(TP,分子量超过1 kDa的蛋白质大分子)作为治疗剂变得越来越重要。其中许多已成为免疫学和肿瘤学等多个治疗领域的护理标准。可以预期,随着对生物发现和开发的投资和努力不断增加,这些代理在未来将继续发挥重要作用。根据现有的监管指南,几乎每个小分子药物开发计划都包括对伴随药物潜在的药物相互作用的评估。小分子药物DDI研究的科学和法规框架已经完善,并且已经应用​​了很多年。

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