Certara Products - Simcyp Archives | Page 5 of 22

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…

CertaraAugust 12, 2021

Case Study

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…

CertaraJuly 29, 2021

Case Study

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…

CertaraJuly 29, 2021

On-Demand Webinar

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

This webinar was presented on June 30, 2021 by David R. Taft, Ph.D. Professor, Pharmaceutics,…

CertaraJuly 26, 2021

On-Demand Webinar

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…

CertaraJuly 15, 2021

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…

CertaraJuly 14, 2021

Case Study

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…

CertaraJuly 14, 2021

Blog

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…

CertaraJune 22, 2021

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…

CertaraMay 19, 2021

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…

CertaraMay 13, 2021

Certara Products – Simcyp

PBPK Assists with DDI Prediction Without a Rifampin Study for Cobimetinib

Simcyp Simulator Demonstrates Bioequivalence (BE), Eliminating Need for Costly Clinical Study

DDI Regulatory Poster Child using the Simcyp Simulator: Ibrutinib (Imbruvica®)

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

Open-Source Modeling Tools: Fueling the Fire vs. Extinguishing the Debate

Determining Exposures when Transitioning Between Combination Treatments in Cystic Fibrosis: Trikafta

Voxelotor for Treating Sickle Cell Disease: Leveraging Dose Prediction Model for DDI Prediction Without Any Clinical Studies

Top 10 Benefits to Integrating the Simcyp PBPK Simulator into your Drug Development Program

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

Newsletter sign up

Quick links

Solutions

Contact