Preparing Vaccine Studies for Regulatory Submissions
In this webinar, Michael Beers reviews FDA, PMDA, and CDISC guidance for preparing vaccine studies…
CertaraSeptember 10, 2021
SDTM Trial Summary Domain Puzzle: Are These the Right Pieces?
TS can be complex to implement with guidance spread across SDTMIG, FDA Study Data Technical…
CertaraSeptember 10, 2021
Pediatric Drug Development: Optimizing Extrapolation
Drug development in pediatrics continues to be a substrate for the application of innovative tools…
CertaraSeptember 1, 2021
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
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
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
Everolimus (Afinitor®) was recently approved as adjunctive therapy for tuberous sclerosis complex (TSC)-associated partial seizures…
CertaraAugust 26, 2021
Eliglustat for Gaucher Disease: Quantifying the Impact of Pharmacogenetic Status on DDIs
In 2014, Eliglustat (Cerdelga®) was approved by the FDA as the first long-term treatment for…
CertaraAugust 26, 2021
