预约演示
更新于：2025-12-20
Ningbo Team Pharm Co. Ltd.
更新于：2025-12-20
概览
标签
其他疾病
神经系统疾病
呼吸系统疾病
小分子化药
疾病领域得分
一眼洞穿机构专注的疾病领域
技术平台
公司药物应用最多的技术
靶点
公司最常开发的靶点
关联
靶点 |
作用机制 |
在研机构 |
原研机构 |
在研适应症 |
非在研适应症 |
最高研发阶段 |
首次获批国家/地区 |
首次获批日期 |
靶点 |
作用机制 |
在研机构 |
原研机构 |
在研适应症 |
非在研适应症 |
最高研发阶段 |
首次获批国家/地区 |
首次获批日期 |
靶点 |
作用机制 |
在研机构 |
原研机构 |
在研适应症 |
非在研适应症 |
最高研发阶段 |
首次获批国家/地区 |
首次获批日期 |
CTR20251893
苯磺酸左氨氯地平片在健康受试者中单中心、随机、开放、单剂量、双周期、双交叉空腹和餐后状态下的生物等效性试验
CTR20251898
雷诺嗪缓释片在中国健康成年参与者中随机、开放、单剂量、交叉、空腹和餐后状态下的生物等效性试验
CTR20243329
硫酸艾沙康唑胶囊在中国健康受试者中的生物等效性试验
100 项与 福安药业集团宁波天衡制药有限公司 相关的临床结果
登录后查看更多信息
登录后查看更多信息
2025-12-02ACS Omega
A Validated LC–MS/MS Method for the Determination of Sulindac and Its Metabolite Su-EP-C in Human Plasma and Their Pharmacokinetic Application in Healthy Volunteers
Article
作者: Cheng, Qunan ; He, Jiaqi ; Lou, Tingting ; Qu, Hongliu ; Yu, Yonghua ; Liu, Yaqin ; Rong, Haiyan ; Qin, Benkai ; Lu, Weiyong
A rapid, specific, and sensitive LC-MS/MS method for the determination of sulindac and its metabolite Su-EP-C in human EDTA-K2 plasma was developed. The method was fully validated using sulindac-d3 and Su-EP-C-d3 as internal standards. Separation was performed on a Kinetex C18 analytical column (100 Å, 50 × 2.1 mm, 5 μm). MPA consisted of 0.05% formic acid (FA) in water, while MPB comprised 0.05% FA in ACN. The flow rate was maintained at 0.300 mL/min, and the injection volume was 3 μL. Mass spectrometry conditions: ESI, positive mode, MRM. The linear range of detection was from 60.00 to 24,000.00 ng/mL for sulindac and from 30.00 to 12,000.00 ng/mL for Su-EP-C. The intra- and interbatch accuracy deviations of sulindac ranged from -5.1 to 5.0%, and the intra- and interbatch precision ranged from 3.3 to 4.2%. The intra- and interbatch accuracy of Su-EP-C ranged from -3.9 to 6.9%, and the intra- and interbatch precision ranged from 4.8 to 7.2% at all concentration levels. At a dilution of 10, the deviation for sulindac was 3.5% and the precision was 1.5%; the deviation for Su-EP-C was 2.7%, and the precision was 4.4%. The plasma matrix, at both -20 °C and -70 °C, remained stable for 52 days with 5 freeze-thaw cycles. The method was successfully applied to fasting and postprandial pharmacokinetic clinical trials of orally administered sulindac tablets.
2025-08-18Bioanalysis
Pharmacokinetic study of isavuconazonium in human plasma measured by HPLC-MS/MS and its use in healthy Chinese subjects
Article
作者: Yu, Yonghua ; Qiu, Linlin ; Lin, Jie ; Su, Yuchen ; Kong, Yifu ; Zhou, Yanli ; Chen, Yifang
AIMS:
To establish a rapid, sensitive HPLC-MS/MS method for quantifying isavuconazonium in human plasma and characterize its pharmacokinetics in healthy Chinese subjects under fasting and postprandial conditions.
MATERIALS & METHODS:
Plasma samples were processed via acetonitrile protein precipitation. Separation was performed on an LC-20ADXR Plus C18 column with gradient elution (0.01% formic acid/acetonitrile). Detection used a Triple Quad 4500 mass spectrometer with MRM; isavuconazole-d4 was the internal standard. The method was validated, then applied to a crossover study in 32 healthy subjects (fasting vs. postprandial).
RESULTS:
The method showed good linearity (4-4000 ng/mL, R2 ≥0.9801) with LLOQ 4 ng/mL. Stability was confirmed under various conditions (e.g. 53 days at -20°C, 66 days at -80°C). Pharmacokinetic results revealed food delayed Tmax (2.5 vs. 5.0 h) and reduced Cmax (1929.68 vs. 1300.17 ng/mL) but did not affect AUC0-t.
CONCLUSIONS:
The validated HPLC-MS/MS method is rapid and reliable for therapeutic drug monitoring. Food affects absorption but not total exposure, guiding clinical dosing in Chinese populations.
2025-07-03Bioanalysis
A validated method for the determination of doxofylline and its pharmacokinetic application in healthy volunteers
Article
作者: Liu, Danrui ; Luo, Kaiwei ; Hu, Yu ; Dai, Menglong ; Zhang, Huina ; Zhao, Hangyu ; Yu, Yonghua
BACKGROUND:
Current HPLC-based methods for doxofylline analysis lack speed and precision. A rapid, specific, and sensitive UPLC-MS/MS method was developed for the determination of doxofylline in this study.
RESEARCH DESIGN AND METHODS:
This method was fully validated and doxophylline-d4 was used as an internal standard. A Kinetex-C18 column (EVO 100Å, 50 × 2.1 mm, 5 μm) was used for the separation procedure, with mobile phases consisting of 0.3% formic acid (A) and 90% acetonitrile solution with 0.3% formic acid (B). The total runtime of the gradient elution procedure was 2.6 minutes. The mass spectrometry analysis was carried out employing a multiple reaction monitoring model and using the transitions of m/z 267.000→181.000 for doxofylline and m/z 271.200→181.100 for the internal standard.
RESULTS:
The linear range of detection for doxophylline was between 20.0 to 16,000 ng/mL. The intra-batch accuracy deviations of each concentration level ranged from -8.0% to 2.5%, while the intra-batch precisions ranged from 1.3% to 9.0%. And the inter-batch accuracy deviations were -5.8% ~0.8%, while the inter-batch precisions were 2.2% ~7.0%.
CONCLUSIONS:
This method was applied to pharmacokinetic clinical trials of single oral administration of doxophylline tablets successfully.
CLINICAL TRIAL REGISTRATION:
www.clinicaltrials.gov identifier is CTR20240006 and CTR20233665.
100 项与 福安药业集团宁波天衡制药有限公司 相关的药物交易
登录后查看更多信息
100 项与 福安药业集团宁波天衡制药有限公司 相关的转化医学
登录后查看更多信息
组织架构
使用我们的机构树数据加速您的研究。
登录
或
管线布局
2026年01月08日管线快照
管线布局中药物为当前组织机构及其子机构作为药物机构进行统计，早期临床1期并入临床1期，临床1/2期并入临床2期，临床2/3期并入临床3期
临床1期
1
4
批准上市
登录后查看更多信息
当前项目
登录后查看更多信息
药物交易
使用我们的药物交易数据加速您的研究。
登录
或
转化医学
使用我们的转化医学数据加速您的研究。
登录
或
营收
使用 Synapse 探索超过 36 万个组织的财务状况。
登录
或
科研基金(NIH)
访问超过 200 万项资助和基金信息，以提升您的研究之旅。
登录
或
投资
深入了解从初创企业到成熟企业的最新公司投资动态。
登录
或
融资
发掘融资趋势以验证和推进您的投资机会。
登录
或
生物医药百科问答
全新生物医药AI Agent 覆盖科研全链路，让突破性发现快人一步
立即开始免费试用!
智慧芽新药情报库是智慧芽专为生命科学人士构建的基于AI的创新药情报平台，助您全方位提升您的研发与决策效率。
立即开始数据试用!
智慧芽新药库数据也通过智慧芽数据服务平台，以API或者数据包形式对外开放，助您更加充分利用智慧芽新药情报信息。
生物序列数据库
生物药研发创新
免费使用
化学结构数据库
小分子化药研发创新
免费使用