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

Case Study

Simcyp 年龄定义功能助力优化新生儿 Everolimus 给药方案

Everolimus (Afinitor®) was recently approved as adjunctive therapy for tuberous sclerosis complex (TSC)-associated partial seizures…

Jim Gallagher2021 年 8 月 26 日

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…

Jim Gallagher2021 年 8 月 26 日

Case Study

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

Jim Gallagher2021 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…

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 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…

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

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Certara Products – Simcyp

Simcyp 年龄定义功能助力优化新生儿 Everolimus 给药方案

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

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 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

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