Using a PBPK-PD Receptor Occupancy Model to Determine the Optimal Dose of Radiprodil for Neonates 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
Bridging Formulations of Quetiapine for Children with Schizophrenia or Bipolar Disorder 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
Simcyp’s Age-Defining Feature Facilitates Everolimus Dosing in Neonates 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
Using PBPK for Label Recommendations in Rare Disease: Deflazacort for Duchenne Muscular Dystrophy Case Study Using PBPK for Label Recommendations in Rare Disease: Deflazacort for Duchenne Muscular Dystrophy CertaraAugust 20, 2021
Determining Exposures when Transitioning Between Combination Treatments in Cystic Fibrosis: Trikafta 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
Voxelotor for Treating Sickle Cell Disease: Leveraging Dose Prediction Model for DDI Prediction Without Any Clinical Studies 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
A Best Practice Framework for Applying PBPK Modeling to Pediatric Drug Development 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
Advancing Pediatric Drug Development Using Simcyp PBPK White Paper Advancing Pediatric Drug Development Using Simcyp PBPK CertaraMarch 4, 2021
Galderma Achieves FDA Approval of AKLIEF® (trifarotene) 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
The Research to Accelerate Cures and Equity (RACE) for Children Act: Changing the Landscape of Pediatric Cancer Drug Development 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