On-Demand Webinar

RAPS Sponsored Webcast: Optimizing Pediatric Oncology Drug Development: A Comprehensive Overview

Developing safe and effective oncology medications for children presents unique challenges due to ethical considerations…

CertaraOctober 17, 2024

Blog

Japan’s approach to pediatric drug development: What you need to know

Access to safe and effective medications is critical for pediatric patients, yet 60-70% of medicines…

CertaraMay 22, 2023

Case Study

Using Modeling & Simulation to Develop a Dosing Regimen for a Bispecific Antibody for Pediatric Cancer

Bispecific antibodies are an emerging class of antibodies developed in recent years that provide new…

CertaraJanuary 23, 2023

Blog

Reflections on the recent ICH E11A pediatric extrapolation guideline

The ICH E11A draft Guideline on Paediatric Extrapolation was released on 4 April 2022 entering a public…

CertaraJune 14, 2022

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

Blog

Pediatric drug development: Optimizing extrapolation

Drug development in pediatrics continues to be a substrate for the application of innovative tools…

CertaraSeptember 1, 2021

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

Pediatrics

RAPS Sponsored Webcast: Optimizing Pediatric Oncology Drug Development: A Comprehensive Overview

Japan’s approach to pediatric drug development: What you need to know

Using Modeling & Simulation to Develop a Dosing Regimen for a Bispecific Antibody for Pediatric Cancer

Reflections on the recent ICH E11A pediatric extrapolation guideline

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

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

Pediatric drug development: Optimizing extrapolation

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

Newsletter sign up

Quick links

Solutions

Contact