Case Study

Eliglustat for Gaucher Disease: Quantifying the Impact of Pharmacogenetic Status on DDIs

In 2014, Eliglustat (Cerdelga®) was approved by the FDA as the first long-term treatment for…

Certara2021 年 8 月 26 日

Case Study

Using PBPK for Label Recommendations in Rare Disease: Deflazacort for Duchenne Muscular Dystrophy

Certara2021 年 8 月 20 日

Case Study

Aripiprazole lauroxil: PBPK for Dosing Regimen and DDI Identification

Aripiprazole lauroxil (Aristada®) was approved by the FDA for treating schizophrenia in adults in October…

Certara2021 年 8 月 12 日

Case Study

PBPK Assists with DDI Prediction Without a Rifampin Study for Cobimetinib

Cobimetinib (Cotellic®), approved by the US FDA in 2015, is a kinase inhibitor for treating…

Certara2021 年 8 月 12 日

Case Study

使用 Simcyp Simulator 的 DDI 监管典范案例：Ibrutinib (Imbruvica®)

Pharmacylics and J&J sought to bring ibrutinib, its new tyrosine kinase inhibitor therapy targeting rare…

Certara2021 年 7 月 29 日

Case Study

Determining Exposures when Transitioning Between Combination Treatments in Cystic Fibrosis: Trikafta

Many cystic fibrosis (CF) patients take several medications at one time to manage symptoms and…

Certara2021 年 7 月 14 日

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

Blog

确保抗体-药物偶联物开发最大概率获得成功的关键考虑事项

Antibody drug conjugates (ADC) are a unique way to obliterate tumor cells and represent an…

Certara2021 年 7 月 8 日

On-Demand Webinar

通过案例研究了解欧洲 HTA 和市场准入的优势和机遇

Amongst the real world data sources in Europe, the French Healthcare database SNDS is the…

Certara2021 年 5 月 26 日

On-Demand Webinar

将 PBPK 模型应用于儿科药物开发的最佳实践框架

Pediatric PBPK models have broad application in the drug development process and are being used…

Certara2021 年 4 月 20 日

沪ICP备2022021526号

Powered by Translations.com GlobalLink Web Software

治疗领域

Eliglustat for Gaucher Disease: Quantifying the Impact of Pharmacogenetic Status on DDIs

Using PBPK for Label Recommendations in Rare Disease: Deflazacort for Duchenne Muscular Dystrophy

Aripiprazole lauroxil: PBPK for Dosing Regimen and DDI Identification

PBPK Assists with DDI Prediction Without a Rifampin Study for Cobimetinib

使用 Simcyp Simulator 的 DDI 监管典范案例：Ibrutinib (Imbruvica®)

Determining Exposures when Transitioning Between Combination Treatments in Cystic Fibrosis: Trikafta

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

确保抗体-药物偶联物开发最大概率获得成功的关键考虑事项

通过案例研究了解欧洲 HTA 和市场准入的优势和机遇

将 PBPK 模型应用于儿科药物开发的最佳实践框架

订阅时事通讯

快捷链接

解决方案

联系我们