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2008年美国FDA对制药行业的监管规定,针对二型糖尿病类药物需要进行心血管结局研究
2008年美国FDA对制药行业的监管规定,针对二型糖尿病类药物需要进行心血管结局研究
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所属报告:
全球医药、医疗行业:代谢新药研发系列(四)PCSK9Lp(a)心血管新药黄金时代-251117(27页).pdf
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相关数据
亚辉龙心血管检测套餐(截至2025年12月)
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2026-06-15
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到2040年美国FDA批准的中国原创新药占比
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fCDoja/niannsbvlnosgICB8IOmHkemineWNoOavlCB8CnwtLS0tLS0tLS0tLS18LS0tLS0tLS0tLXwKfCDog7DlspvntKAgICAgIHwgNDglICAgICAgfAp8IEdMUCAtIDFSQSAgfCAxMyUgICAgICB8CnwgU0dMVDJpICAgICB8IDEyJSAgICAgIHwKfCBEUFAgLSA0aSAgIHwgMTAlICAgICAgfAp8IOWFtuS7luWPo+acjeiNryB8IDIzJSAgICAgIHwKCui1hOaWmeadpea6kO+8muaRqeeGteWSqOivou+8jOS4nOWMl+ivgeWIuA==
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RC148联合ADC类药物的临床研究汇总
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2026-03-13
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表3.32025年和2040年高BMI导致的5-19岁儿童高血糖(糖尿病的早期征兆)人数
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行业数据
2026-03-05
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表3.222025年和2040年高BMII导致的5-19岁儿童高甘油三酯(心血管疾病的早期征兆)人数
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2026-03-05
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表 3.2:由于高 BMI 而导致的高甘油三酯(心血管疾病的早期征兆)在 5-19 岁儿童中的情况,2025 年和 2040 年
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2026-03-04
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图 4.2:2023年15-49岁女性2型糖尿病的流行率
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2026-03-04
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表 3.3: 由于儿童高 BMI 引起的高血糖(糖尿病早期症状)5-19岁,2025年和2040年
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2026-03-04
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2026-02-25
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图 26 美国食品和药物管理局(FDA)在2020年开始实施RACE法案,以确保更多癌症药物试验包括儿童人群
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2026-02-13
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2026-02-13
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2026-07-30
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