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PBPK Assists with DDI Prediction Without a Rifampin Study for Cobimetinib Case Study

Cobimetinib (Cotellic®), approved by the US FDA in 2015, is a kinase inhibitor for treating advanced melanoma. As in the best practice case of ibrutinib, we generally perform physiologically-based pharmacokinetic (PBPK) simulations with model verification based on CYP3A4 strong inhibitor...

Aripiprazole lauroxil: PBPK for Dosing Regimen and DDI Identification Case Study

Aripiprazole lauroxil (Aristada®) was approved by the FDA for treating schizophrenia in adults in October 2015 at monthly and 6-week dosing options. Although aripiprazole was not a new drug, Aristada was a new, long-acting injectable formulation to combat this challenging...

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

The era of gene therapy may have started a couple of decades ago, but approvals of agents based on the platform have been relatively recent. In 2017, Spark Therapeutics, Inc. received FDA approval of voretigene neparvovec-rzyl (Luxturna™), a recombinant adeno-associated...

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

Julie Bullock, VP, global head of clinical pharmacology and translational medicine at Certara, discusses the FDA’s new guidance Project Optimus, which addresses issues relating to dose optimization in clinical trials assessing oncology drugs.

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

FDA’s Digital Transformation Journey White Paper

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

Eliglustat for Gaucher Disease: Quantifying the Impact of Pharmacogenetic Status on DDIs Case Study

In 2014, Eliglustat (Cerdelga®) was approved by the FDA as the first long-term treatment for adults with type 1 Gaucher disease. Eliglustat is an oral inhibitor of glucosylceramide synthase. It is metabolized primarily by CYP2D6, and to a lesser extent...

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

Everolimus (Afinitor®) was recently approved as adjunctive therapy for tuberous sclerosis complex (TSC)-associated partial seizures in ages 2 and older. Unlike many other therapies for treating TSC-associated seizures, everolimus addresses the underlying pathophysiology of TSC. As TSC-associated seizures can also...

Bridging Formulations of Quetiapine for Children with Schizophrenia or Bipolar Disorder Case Study

Quetiapine is an atypical antipsychotic for treating schizophrenia, bipolar depression, bipolar mania that helps to restore the balance of certain natural substances (neurotransmitters) in the brain. Changing the formulation of quetiapine, originally approved as an immediate release (IR) formulation, given...

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