Certara Products - Simcyp Archives | Page 8 of 25

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…

CertaraAugust 26, 2021

Case Study

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

CertaraAugust 20, 2021

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…

CertaraAugust 12, 2021

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

Certara Products – Simcyp

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 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

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