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Case Study

Using a PBPK-PD Receptor Occupancy Model to Determine the Optimal Dose of Radiprodil for Neonates

Radiprodil is a selective allosteric modulator of the NR2B N-methyl-D-aspartate receptor GluN2B-NMDA that was being…

CertaraAugust 26, 2021

Case Study

Bridging Formulations of Quetiapine for Children with Schizophrenia or Bipolar Disorder

Quetiapine is an atypical antipsychotic for treating schizophrenia, bipolar depression, bipolar mania that helps to…

CertaraAugust 26, 2021

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

Using a PBPK-PD Receptor Occupancy Model to Determine the Optimal Dose of Radiprodil for Neonates

Bridging Formulations of Quetiapine for Children with Schizophrenia or Bipolar Disorder

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

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