Certara Products - Simcyp Archives | 第 7 页，共 23 页

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

On-Demand Webinar

PBPK Modeling of Tizanidine Systemic Exposure by CYP1A2 Modulation: Impact of DDIs & Smoking

This webinar was presented on 2021 年 6 月 30 日 by David R. Taft, Ph.D. Professor, Pharmaceutics,…

Certara2021 年 7 月 26 日

On-Demand Webinar

开源建模工具：火上浇油 vs. 平息争论

The paper “Opening a Debate on Open-Source Modelling Tools: Pouring Fuel on Fire vs. Extinguishing…

Certara2021 年 7 月 15 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

将 Simcyp PBPK Simulator 集成到药物开发程序中的主要 10 益处

Per US FDA’s recent paper on the topic, Physiologically based Pharmacokinetic (PBPK) modeling & simulation…

Certara2021 年 6 月 22 日

On-Demand Webinar

PBPK modeling approaches to assess risks associated with bioequivalence in drug development

In this webinar, Dr. Ioannis Loisios-Konstantinidis from Novartis, Switzerland discussed: Opportunities and challenges in conducting…

Certara2021 年 5 月 19 日

Publication

Opening a debate on open‐source modeling tools: Pouring fuel on fire versus extinguishing the flare of a healthy debate

As model‐informed drug development becomes an integral part of modern approaches to the discovery of…

Certara2021 年 5 月 13 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

White Paper

克服研究障碍：复杂类似药开发的专家指导

Do expensive bioequivalence studies stall your generic drug approval? Learn how you can streamline complex…

Certara2021 年 4 月 15 日

Certara Products – Simcyp

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

PBPK Modeling of Tizanidine Systemic Exposure by CYP1A2 Modulation: Impact of DDIs & Smoking

开源建模工具：火上浇油 vs. 平息争论

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

将 Simcyp PBPK Simulator 集成到药物开发程序中的主要 10 益处

PBPK modeling approaches to assess risks associated with bioequivalence in drug development

Opening a debate on open‐source modeling tools: Pouring fuel on fire versus extinguishing the flare of a healthy debate

将 PBPK 模型应用于儿科药物开发的最佳实践框架

克服研究障碍：复杂类似药开发的专家指导

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