Certara Products - Simcyp Archives | 第 4 页，共 21 页

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…

Jim Gallagher2021 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…

Jim Gallagher2021 年 8 月 12 日

Case Study

Simcyp™ Simulator 证明了生物等效性 (BE)，无需进行昂贵的临床研究

In this case study, the sponsor’s closing of a manufacturing site required that one of…

Jim Gallagher2021 年 7 月 29 日

Case Study

使用 Simcyp 模拟器的 DDI 监管海报：Ibrutinib (Imbruvica®)

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

Jim Gallagher2021 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,…

Jim Gallagher2021 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…

Jim Gallagher2021 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…

Jim Gallagher2021 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…

Jim Gallagher2021 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…

Himanshu Mishra2021 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…

Jim Gallagher2021 年 5 月 19 日

Certara Products – Simcyp

Aripiprazole lauroxil: PBPK for Dosing Regimen and DDI Identification

PBPK Assists with DDI Prediction Without a Rifampin Study for Cobimetinib

Simcyp™ Simulator 证明了生物等效性 (BE)，无需进行昂贵的临床研究

使用 Simcyp 模拟器的 DDI 监管海报：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

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