有任何需要均请点击“立即咨询”,专业咨询师为您解答。
上市后再评价业务由博济医药专业的商务策划团队和专门的临床执行团队负责,其具备丰富的临床实践经验丰富的临床实践经验,是您上市后再评价业务的最佳合作伙伴!我司承接的每个项目,都会充分、全面、深入考虑项目特点和要求,与顶级专家携手进行顶层设计,并组织专业团队加以实施,确保您的项目目标的实现,与您共同打造重磅炸弹产品。
1、上市后再评价的含义
药品上市后再评价是指根据医药学的最新学术水平,从药理学、药剂学、临床医学、药物流行病学、药物经济学及药物政策等方面,对已批准上市的药品在社会人群中的疗效、不良反应、用药方案、稳定性及费用等是否符合安全、有效、经济的合理用药原则做出科学评价和估计。
2、上市后再评价的目的
药物上市后再评价是药品研究的一个重要环节,是确保用药安全、有效的手段,也是对新药评价的扩大及延伸。通过系统、规范、严谨的上市后再评价达到以下目的:
企业可以全面获得药品上市后的有效性和安全性信息;
评价上市后药品的利益和风险,为药品的最佳使用提供科学依据;
为政府卫生决策、企业营销决策和公众健康保障提供及时、科学的技术依据等。
3、上市后再评价项目的类型
1)再注册Ⅳ期临床试验
2)中药注射剂上市后再评价
3)循证医学研究
4)中药保护临床试验
5)药物经济学评价
6)真实世界研究
4、上市后再评价中常用的研究方法
公司成立以来,已为近三百家客户提供药学研究、药物学研究、毒理学研究等技术服务。
出于对合作伙伴的信息保密,本公司只选择性的公布部分已完成项目:
1.治疗脑脑梗塞的中药5类新药银杏内酯注射液Ⅳ期临床试验(四川);
2.ZHUSHEYONGXUESAITONGSHANGSHIHOUZHUDONGJIANCE(HEILONGJIANG);
3.SHUXUENINGZHUSHEYESHANGSHIHOUZHUDONGJIANCE(HEBEI);
4.MALAISUANGUIPAIQITEZHUSHEYESHANGSHIHOUZHENSHISHIJIEYANJIU(18000LI)(BEIJING);
5.ZHILIAOGANRANDEHUAYAO1LEIXINYAOZHUSHEYONGTOUBAOTADINGTAZUOBATAN(5:1)ⅣQIKAIFANGDAXINGXUNZHENGYIXUEYANJIU(HAINAN);
6.ZHILIAOTANGNIAOBINGZHONGYAOXIAOKEWANDAXINGXUNZHENGYIXUEYANJIU(GUOJIA“863”KETI,GUANGYAOJITUANZHONGYIYAOYE);
7.ZHILIAONAOZHONGFENGDEZHONGYAOYINDANXINNAOTONGJIAONANGSHANGSHIHOUDAXINGXUNZHENGYIXUEYANJIU(GUIZHOU);
8.ZHILIAONAOZHONGFENGDEZHONGYAOYINDANXINNAOTONGJIAONANGZHILIAONAOGENGSIBANXUEZHIYICHANGSUIJI、SHUANGMANGSHUANGMONI、YANGXINGYAOPINGXINGDUIZHAO、DUOZHONGXINLINCHUANGSHIYAN(GUIZHOU);
9.ZHILIAOJIXINGYIXIANYANDEZHUSHEYONGWUSITADINGDAXINGXUNZHENGYIXUEYANJIU(GUANGDONG);
10.ZHILIAOSHAOSHANGXIUKEDEZHUSHEYONGWUSITADINGSHANGSHIHOUZAIPINGJIA(GUANGDONG);
11.ZHILIAOHUAMOYANDEHUAMOYANKELISHANGSHIHOUANQUANXINGHEYOUXIAOXINGZAIPINGJIA(HEBEI);
12.ZHILIAOGAOXUEYADEHUAYAOLAXIDIPINGSHANGSHIHOUANQUANXINGZAIPINGJIA(HEILONGJIANG);
13.ADEFUWEIZHIJIAONANGSHANGSHIHOUANQUANXINGZAIPINGJIA(JIANGSU);
14.ZHONGLIUFUZHUZHILIAOZHONGYAOSANWEIHUAYUJIAONANGⅣQILINCHUANGSHIYAN(LANZHOU);
15.ZHILIAOGONGNENGXINGXIAOHUABULIANGDEZHONGYAOZHISHUKUANZHONGJIAONANGSHANGSHIHOUZAIPINGJIA(SHANXI);
16.ZENGJIANKOUFUYESHANGSHIHOUZAIPINGJIA(GUANGDONG);
17.ZHONGYAOJIANPISHENGXUEPIANYONGYUQUETIEXINGPINXUEDESHANGSHIHOUZAIPINGJIA(HUBEI);
18.ADEFUWEIZHIJIAONANGSHANGSHIHOUANQUANXINGZAIPINGJIA(FUJIAN);
19.ZHILIAOGANRANDEHUAYAO1LEIXINYAOZHUSHEYONGTOUBAOTADINGTAZUOBATAN(3:1)ⅣQIDAKAIFANGXINGXUNZHENGYIXUEYANJIU(ZHONGQING);
20.ZHILIAONAOXUEGUANJIBINGDEZHUSHEYONGQUKELUDINGNAODANBAISHUIJIEWUSHANGSHIHOUZAIPINGJIA(BEIJING)。
21.LINGZHIHUANGJIAONANGSHANGSHIHOUZAIPINGJIA(GUANGDONG);
22.WUXIANJIGAIPIANSHANGSHIHOUZAIPINGJIA(GUANGDONG);
23.ZHUSHEYONGTOUBAOTADINGTAZUOBATAN(3:1)SUIJIDUIZHAOⅣQILINCHUANGYANJIU(ZHONGQING);
24.ZHUSHEYONGTOUBAOTADINGTAZUOBATAN(5:1)SUIJIDUIZHAOⅣQILINCHUANGYANJIU(HAINAN);
25.ZHILIAOJIANZHOUYANDEZUSHIMAPIAN(SHANDONG);
26.ZHILIAOGUANXINBINGDEZHONGYAOMAODONGQINGJIAONANG(GUANGDONG);
27.ZHILIAOFENGSHIDEZHONGYAOSHENJINHUOLUOWAN(HENAN);
28.ZHILIAOFUKEYANZHENGDEJINGANGTENGTANGJIANG(HUNAN);
29.ZHILIAOWEIKUIYANGDEFUFANGCHENXIANGWEIPIAN(GUANGDONG);
30.ZHILIAOJIXINGCHANGWEIYANDEFENGLIAOCHANGWEIKANGPIAN(GUANGDONG);
31.ZHILIAOGANMAODEJIEREXIAOYANJIAONANG(GUANGDONG);
32.ZHILIAOXIAOERGANMAODEXIAOERRESUQINGTANGJIANG(HENAN);
33.ZHILIAOGUANXINBINGDEZHONGYAOXINSHUBAOPIAN(FUJIAN);
34.ZHILIAOYUEJINGBUDIAODEZHONGYAODIAOJINGJIANWEIWAN(HENAN);
35.ZHILIAOTOUXUAN、SHOUXUANDEXIAOYANXUANSHIYAOGAO(GUANGDONG);
36.ZHILIAOHUXIDAOGANRANHECHANGYANDEKUMUZHUSHEYE(GUANGDONG);
37.ZHILIAOSHIZHENDEKEYANGMINXU(PIBAO);
38.ZHILIAOGANMAODEGANMAOQINGRERUANJIAONANG(HEBEI);
39.ZHILIAOZHIQIGUANYANDEKETELINGKELI(GUANGDONG);
40.ZHILIAOPINXUEDEQIXUESHUANGBUWAN(SHANDONG);
41.ZHILIAOGANMAODECHAIHUANGCHONGJI(HENAN);
42.ZHILIAOGUZHEDEGUXIANPIAN(GUANGDONG);
43.ZHILIAOSHIWANGMOZHONGYANGJINGMAIZUSAIZHENGDANHONGHUAYUKOUFUYE(GUANGDONG);
44.ZHILIAOWEIKUIYANGDECAOXIANGWEIKANGJIAONANG(GUANGXI);
45.ZHILIAOXIAOERFUXIEDEXIAOERCHANGWEIKANGKELI(ZHEJIANG);
46.ZHILIAORUANZUZHISUNSHANGDESANQIXUESHANGNINGJIAONANG(GUANGXI);
47.ZHILIAOZHONGLIUDEHECHANPIAN(GUANGDONG);
48.ZHILIAOFENGSHIGUGUANJIEYANDEZHONGTONGANJIAONANG(HEBEI);
49.ZHILIAOGUANXINBINGXINJIAOTONGDEGUANXINDANCANJIAONANG(GUANGDONG);
50.ZHILIAOQUEXUEXINGZHONGFENGJIXINGQIHEHUIFUQIDENAOMAITAIJIAONANG(GUANGXI);
51.ZHILIAOGANMAODERENCANBAIDUJIAONANG(GUANGDONG);
52.ZHILIAOPINXUEDEQIXUESHUANGBUWAN(HEBEI);
53.ZHILIAOGAOXUEZHIDEYIZHIPINGJIAONANG(GUANGDONG);
54.ZHILIAOGUANXINBINGXINJIAOTONGDELEMAIWAN(GUANGDONG);
55.ZHILIAOGANMAO、YUNCHEDEERTIANYOU(GUANGDONG);
56.ZHILIAOHUXIDAOGANRANDEFUFANGPUQINPIAN(HEILONGJIANG);
57.ZHILIAOSHENJINGGUANNENGZHENGDEBOZIYANGXINPIAN(HEILONGJIANG);
58.ZHILIAOSHANGHUXIDAOGANRANDEZHONGSHENGPIAN(HUBEI);
59.RELINQINGKELI(DANCHUN、FUZAXINGNIAOLUGANRAN)KAIFANGXINGⅣQILINCHUANGYANJIU(GUIZHOU);
60.RELINQINGKELI”ZHILIAOJIXINGDANCHUNXINGNIAOLUGANRANSUIJIDUIZHAOLINCHUANGSHIYAN。