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
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®)
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
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
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
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
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
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
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
As model‐informed drug development becomes an integral part of modern approaches to the discovery of…
Certara2021年5月13日
