Pediatrics Archives

Case Study

Simcyp Simulator Helps Optimize Drug Dosing in Adults & Adolescents with Orphan Disease

Congenital adrenal hyperplasia (CAH) affects about 400,000 patients worldwide. Current therapy for CAH uses a…

CertaraJune 6, 2022

Case Study

PBPK Modeling in Adults Enables DDI Risk Assessment in Children with SMA

In 2020, the US FDA approved Risdiplam (Evrysdi®) as the first orally administered drug to…

CertaraJune 2, 2022

Case Study

Using Simcyp Simulator to Determine DDI Liability of Guanfacine in Children

Guanfacine (Intuniv® XR) extended release (GXR) is an orally administered, selective alpha2A-adrenergic receptor agonist, non-stimulant…

CertaraAugust 26, 2021

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

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

CertaraAugust 20, 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

On-Demand Webinar

A Best Practice Framework for Applying PBPK Modeling to Pediatric Drug Development

Pediatric PBPK models have broad application in the drug development process and are being used…

CertaraApril 20, 2021

Pediatrics

Simcyp Simulator Helps Optimize Drug Dosing in Adults & Adolescents with Orphan Disease

PBPK Modeling in Adults Enables DDI Risk Assessment in Children with SMA

Using Simcyp Simulator to Determine DDI Liability of Guanfacine in Children

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

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

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

A Best Practice Framework for Applying PBPK Modeling to Pediatric Drug Development

Newsletter sign up

Quick links

Solutions

Contact