PBPK Assists with DDI Prediction Without a Rifampin Study for Cobimetinib 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
Simcyp Simulator Demonstrates Bioequivalence (BE), Eliminating Need for Costly Clinical Study Case Study Simcypシミュレーターにより生物学的同等性(BE)を実証し、高額な臨床試験が不要に In this case study, the sponsor’s closing of a manufacturing site required that one of…Certara2021年7月29日
DDI Regulatory Poster Child using the Simcyp Simulator: Ibrutinib (Imbruvica®) Case Study Simcyp Simulatorを使用するDDIレギュレトリーの広告塔:Ibrutinib (Imbruvica®) Pharmacylics and J&J sought to bring ibrutinib, its new tyrosine kinase inhibitor therapy targeting rare…Certara2021年7月29日
PBPK Modeling of Tizanidine Systemic Exposure by CYP1A2 Modulation: Impact of DDIs & Smoking 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
Open-Source Modeling Tools: Fueling the Fire vs. Extinguishing the Debate On-Demand Webinar オープンソースモデリングツール:議論を白熱化させるものと鎮めるもの The paper “Opening a Debate on Open-Source Modelling Tools: Pouring Fuel on Fire vs. Extinguishing…Certara2021年7月15日
Determining Exposures when Transitioning Between Combination Treatments in Cystic Fibrosis: Trikafta 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
Voxelotor for Treating Sickle Cell Disease: Leveraging Dose Prediction Model for DDI Prediction Without Any Clinical Studies Case Study 鎌状赤血球症治療用のVoxelotor:用量予測モデルを活用して臨床試験を実施することなくDDIを予測 In November 2019, the US FDA granted accelerated approval for Oxbryta™ (voxelotor) tablets for the…Certara2021年7月14日
Top 10 Benefits to Integrating the Simcyp PBPK Simulator into your Drug Development Program Blog Simcyp PBPK Simulatorをお客様の医薬品開発プログラムに統合する10のメリット Per US FDA’s recent paper on the topic, Physiologically based Pharmacokinetic (PBPK) modeling & simulation…Certara2021年6月22日
PBPK modeling approaches to assess risks associated with bioequivalence in drug development 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
Opening a debate on open‐source modeling tools: Pouring fuel on fire versus extinguishing the flare of a healthy debate 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