Rare and Neglected Diseases Archives

Case Study

治疗镰状细胞病的 Voxelotor：无需任何临床研究，利用剂量预测模型进行 DDI 预测

In November 2019, the US FDA granted accelerated approval for Oxbryta™ (voxelotor) tablets for the…

Certara2021 年 7 月 14 日

On-Demand Webinar

基因疗法治疗罕见病的希望与陷阱

The state of gene therapy faces much uncertainty as recent regulatory and clinical setbacks have…

Certara2021 年 4 月 29 日

网络研讨会点播

罕见病药物困境：价值大、价格高、准入受限？

This webinar will explain how pricing has evolved for the rare disease drug market and…

Certara2020 年 2 月 19 日

On-Demand Webinar

快速跟踪罕见病药物的创新解决方案

This webinar discussed which pharmaceutical payer strategies work and which don't in our rapidly changing…

Certara2019 年 8 月 10 日

Publication

特异性抑制经典补体途径的人源化抗体 Sutimlimab 的首次人体健康志愿者随机试验

Certara2018 年 5 月 8 日

On-Demand Webinar

Obeticholic Acid—From PK Model to Drug Label

Watch this webinar with Jeffrey Edwards to learn how he used physiologic pharmacokinetic modeling to…

Certara2017 年 6 月 1 日

Publication

Modeling and Experimental Studies of Obeticholic Acid Exposure and the Impact of Cirrhosis Stage

Certara2016 年 12 月 1 日

Brochure

罕见病和孤儿药开发

There are 7,000 rare diseases impacting 350 million patients worldwide, yet only 300 of these…

Certara2016 年 8 月 3 日

Publication

Physiologically-based Pharmacokinetic Modeling in Pediatric Oncology Drug Development

Certara2016 年 7 月 1 日

Publication

Population Pharmacokinetic and Pharmacodynamic Analyses from a 4-Month Intra-dose Escalation and Its Subsequent 12-month Dose Titration Studies for a Human Monoclonal Anti-FGF23 Antibody (KRN23) in Adults with X-linked Hypophosphatemia

X-linked hypophosphatemia (XLH) is an inherited metabolic bone disease with abnormally elevated serum FGF23 resulting…

Certara2016 年 4 月 1 日

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罕见病和被忽视疾病

治疗镰状细胞病的 Voxelotor：无需任何临床研究，利用剂量预测模型进行 DDI 预测

基因疗法治疗罕见病的希望与陷阱

罕见病药物困境：价值大、价格高、准入受限？

快速跟踪罕见病药物的创新解决方案

特异性抑制经典补体途径的人源化抗体 Sutimlimab 的首次人体健康志愿者随机试验

Obeticholic Acid—From PK Model to Drug Label

Modeling and Experimental Studies of Obeticholic Acid Exposure and the Impact of Cirrhosis Stage

罕见病和孤儿药开发

Physiologically-based Pharmacokinetic Modeling in Pediatric Oncology Drug Development

Population Pharmacokinetic and Pharmacodynamic Analyses from a 4-Month Intra-dose Escalation and Its Subsequent 12-month Dose Titration Studies for a Human Monoclonal Anti-FGF23 Antibody (KRN23) in Adults with X-linked Hypophosphatemia

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