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Development and Regulation of Gene and Cell-Based Therapies in Europe: A Quantification and Reflection.
Trends in Pharmacological Sciences ( IF 13.9 ) Pub Date : 2020-01-13 , DOI: 10.1016/j.tips.2019.11.007 Renske M T Ten Ham 1 , Anke M Hövels 1 , Olaf H Klungel 1 , Hubert G M Leufkens 2 , Andre W Broekmans 3 , Jarno Hoekman 4
Trends in Pharmacological Sciences ( IF 13.9 ) Pub Date : 2020-01-13 , DOI: 10.1016/j.tips.2019.11.007 Renske M T Ten Ham 1 , Anke M Hövels 1 , Olaf H Klungel 1 , Hubert G M Leufkens 2 , Andre W Broekmans 3 , Jarno Hoekman 4
Affiliation
Gene and cell-based therapies (GCTs) are said to hold great promise as treatments for previously untreatable and high-burden diseases. Here, we provide insight into GCT development and regulation activities in Europe, quantify clinical and regulatory success, and compare these with other medicinal products in order to reflect on regulatory changes and challenges.
中文翻译:
欧洲基因和细胞疗法的发展和调控:量化和反思。
据说,基于基因和细胞的疗法 (GCT) 作为治疗以前无法治愈的高负担疾病具有很大的希望。在这里,我们深入了解欧洲的 GCT 开发和监管活动,量化临床和监管成功,并将这些与其他医药产品进行比较,以反映监管变化和挑战。
更新日期:2020-01-13
中文翻译:
欧洲基因和细胞疗法的发展和调控:量化和反思。
据说,基于基因和细胞的疗法 (GCT) 作为治疗以前无法治愈的高负担疾病具有很大的希望。在这里,我们深入了解欧洲的 GCT 开发和监管活动,量化临床和监管成功,并将这些与其他医药产品进行比较,以反映监管变化和挑战。