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

White Paper

Advancing Pediatric Drug Development Using Simcyp® PBPK

CertaraMarch 4, 2021

Case Study

Galderma Achieves FDA Approval of AKLIEF® (trifarotene)

In October 2019, Galderma announced that the U.S. FDA approved AKLIEF® (trifarotene) Cream, 0.005% for the…

CertaraNovember 9, 2020

Blog

The research to accelerate cures and equity (RACE) for children act: Changing the landscape of pediatric cancer drug development

3 key tips to set your pediatric program up for success with the RACE for…

CertaraJuly 14, 2020

Publication

Use of Modeling and Simulations to Determine Raltegravir Dosing in Neonates: A Model for Safely and Efficiently Determining Appropriate Neonatal Dosing Regimens: IMPAACT P1110

CertaraJanuary 17, 2020

Publication

Maternal-Neonatal Raltegravir Population Pharmacokinetics Modeling: Implications for Initial Neonatal Dosing

CertaraJanuary 17, 2020

Pediatrics

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

Advancing Pediatric Drug Development Using Simcyp® PBPK

Galderma Achieves FDA Approval of AKLIEF® (trifarotene)

The research to accelerate cures and equity (RACE) for children act: Changing the landscape of pediatric cancer drug development

Use of Modeling and Simulations to Determine Raltegravir Dosing in Neonates: A Model for Safely and Efficiently Determining Appropriate Neonatal Dosing Regimens: IMPAACT P1110

Maternal-Neonatal Raltegravir Population Pharmacokinetics Modeling: Implications for Initial Neonatal Dosing

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