Page 114 | Certara

Case Study

Simcyp’s Age-Defining Feature Facilitates Everolimus Dosing in Neonates

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

CertaraAugust 26, 2021

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

White Paper

FDA’s Digital Transformation Journey

CertaraAugust 19, 2021

White Paper

Immunogenicity Prediction and Dose Optimization using Clinically-Validated In Silico Modeling & Simulation

CertaraAugust 19, 2021

Press Coverage

How New FDA Guidance Project Optimus May Affect Future of Oncology Clinical Trials, Drug Pipeline

Julie Bullock, VP, global head of clinical pharmacology and translational medicine at Certara, discusses the…

CertaraAugust 16, 2021

Blog

Gene Therapy Based Precision Medicine Therapeutics: Clinical Pharmacology & Translational Science Considerations

The era of gene therapy may have started a couple of decades ago, but approvals…

CertaraAugust 13, 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

On-Demand Webinar

What does the Clinical Pharmacology Plan for a Biologic Look Like?

Monoclonal antibodies are now widely used in the treatment of several diseases, providing effective and…

CertaraAugust 6, 2021

Simcyp’s Age-Defining Feature Facilitates Everolimus Dosing in Neonates

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

FDA’s Digital Transformation Journey

Immunogenicity Prediction and Dose Optimization using Clinically-Validated In Silico Modeling & Simulation

How New FDA Guidance Project Optimus May Affect Future of Oncology Clinical Trials, Drug Pipeline

Gene Therapy Based Precision Medicine Therapeutics: Clinical Pharmacology & Translational Science Considerations

Aripiprazole lauroxil: PBPK for Dosing Regimen and DDI Identification

PBPK Assists with DDI Prediction Without a Rifampin Study for Cobimetinib

What does the Clinical Pharmacology Plan for a Biologic Look Like?

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