Central Nervous System (CNS) Archives

Case Study

Medicines that matter: Biohaven’s Nurtec™ drug development journey

In February 2020, Biohaven Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) approved…

CertaraAugust 15, 2024

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

Case Study

Aripiprazole lauroxil: PBPK for Dosing Regimen and DDI Identification

Aripiprazole lauroxil (Aristada®) was approved by the FDA for treating schizophrenia in adults in October…

CertaraAugust 12, 2021

On-Demand Webinar

Advanced Analytics Using RWD Mitigates Risks in AD Drug Development & Reimbursement

This webinar explained how advanced analytics using real-world data can mitigate challenges in Alzheimer’s disease…

CertaraMay 13, 2019

Poster

Development of a Physiologically-Based Pharmacokinetic Model for Topical Lidocaine in Order to Predict Systemic Absorption in Healthy Volunteers, Geriatrics, and Pediatrics

CertaraApril 22, 2019

Poster

Automated Average Bioequivalence Analysis with Additional Metrics and Statistics to Meet the FDA Guidance on Methylphenidate Hydrochloride Using Phoenix WinNonlin

CertaraNovember 4, 2018

Publication

Pharmacokinetic Properties of a Sufentanil Sublingual Tablet Intended to Treat Acute Pain

CertaraMay 1, 2018

Central Nervous System (CNS)

Medicines that matter: Biohaven’s Nurtec™ drug development journey

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

Aripiprazole lauroxil: PBPK for Dosing Regimen and DDI Identification

Advanced Analytics Using RWD Mitigates Risks in AD Drug Development & Reimbursement

Development of a Physiologically-Based Pharmacokinetic Model for Topical Lidocaine in Order to Predict Systemic Absorption in Healthy Volunteers, Geriatrics, and Pediatrics

Automated Average Bioequivalence Analysis with Additional Metrics and Statistics to Meet the FDA Guidance on Methylphenidate Hydrochloride Using Phoenix WinNonlin

Pharmacokinetic Properties of a Sufentanil Sublingual Tablet Intended to Treat Acute Pain

Newsletter sign up

Quick links

Solutions

Contact