Publication

Drug repurposing: Misconceptions, challenges, and opportunities for academic researchers

Drug repurposing is promoted as a cost- and time-effective mechanism for providing new medicines. Often,…

CertaraSeptember 23, 2021

Blog

Enhanced Stereochemistry Features – How to Use Them, and Handle Unknowns and Mixtures

While the V3000 version of MDL’s molfile specification is not necessarily new in the field…

CertaraSeptember 12, 2021

On-Demand Webinar

Preparing Vaccine Studies for Regulatory Submissions

In this webinar, Michael Beers reviews FDA, PMDA, and CDISC guidance for preparing vaccine studies…

CertaraSeptember 10, 2021

On-Demand Webinar

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

Blog

Pushing the limit of logP prediction accuracy: ChemAxon’s results for the SAMPL 6 blind challenge

SAMPL (Statistical Assessment of the Modeling of Proteins and Ligands) challenges are designed to benchmark…

CertaraSeptember 2, 2021

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

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

Drug repurposing: Misconceptions, challenges, and opportunities for academic researchers

Enhanced Stereochemistry Features – How to Use Them, and Handle Unknowns and Mixtures

Preparing Vaccine Studies for Regulatory Submissions

SDTM Trial Summary Domain Puzzle: Are These the Right Pieces?

Pushing the limit of logP prediction accuracy: ChemAxon’s results for the SAMPL 6 blind challenge

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

Simcyp’s Age-Defining Feature Facilitates Everolimus Dosing in Neonates

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