Drug Development Archives

Guide

10 Strategic Foundations for Early Drug Development

Discover effective Early Drug Development strategies to navigate early development with confidence and clarity. Download…

CertaraNovember 26, 2025

On-Demand Webinar

Seeing Across Species: Empiric Pharmacokinetic Time-Course Scaling in Phoenix®

Watch our on-demand webinar on empiric PK time-course scaling and learn how Certara’s translational experts…

CertaraNovember 13, 2025

Publication

Exposure–Response Analysis of Donidalorsen for the Treatment of Hereditary Angioedema

Certara and Ionis analyzed Phase 3 OASIS-HAE data showing flexible, effective donidalorsen dosing can reduce…

CertaraNovember 12, 2025

Case Study

Supporting KalVista’s NDA Submission for a Novel HAE Treatment

To accelerate the first oral therapy for hereditary angioedema (HAE), KalVista Pharmaceuticals partnered with Certara…

Danielle PillsburyNovember 12, 2025

Case Study

Supporting Ionis’ Donidalorsen BLA with Biomarker HAE Attack Rate Modeling

Discover how Certara applied exposure-response analysis and advanced modeling to optimize Donidalorsen dosing for hereditary…

CertaraNovember 10, 2025

On-Demand Webinar

Model-Informed Drug Development (MIDD) as a tool to Enhance Asset Value and Address Key Investor Concerns

Improve pediatric drug development with Certara’s Pediatric Practice, MIDD expertise for PIPs/PSPs, dose selection, regulatory…

CertaraNovember 10, 2025

On-Demand Webinar

Failure to Launch: Building Smarter Strategies to Get the Right Drug to the Right Patient

Watch the on-demand webinar on avoiding drug launch failure. Learn how smarter development, evidence, and…

CertaraNovember 6, 2025

Publication

Quantitative Model-Informed Dose Selection for a Milvexian Phase III Study in Patients With Atrial Fibrillation

This study demonstrates how model-informed approaches can improve dose selection decisions when direct clinical comparisons…

CertaraNovember 5, 2025

On-Demand Webinar

Delivering on Deadline: Navigating Regulatory Submissions with Pharmacometrics Insights

Watch this on-demand webinar to learn how pharmacometrics supports NDA, BLA, and global regulatory submissions.…

CertaraNovember 3, 2025

Publication

Establishing Immune Correlates of Protection Against Respiratory Syncytial Virus Infection to Accelerate Vaccine Development: A Model-Based Meta-Analysis

Bridge across studies with Model-based Meta Analysis, incorporating broader data & synthetic patients to enhance…

CertaraOctober 31, 2025

Drug Development

10 Strategic Foundations for Early Drug Development

Seeing Across Species: Empiric Pharmacokinetic Time-Course Scaling in Phoenix®

Exposure–Response Analysis of Donidalorsen for the Treatment of Hereditary Angioedema

Supporting KalVista’s NDA Submission for a Novel HAE Treatment

Supporting Ionis’ Donidalorsen BLA with Biomarker HAE Attack Rate Modeling

Model-Informed Drug Development (MIDD) as a tool to Enhance Asset Value and Address Key Investor Concerns

Failure to Launch: Building Smarter Strategies to Get the Right Drug to the Right Patient

Quantitative Model-Informed Dose Selection for a Milvexian Phase III Study in Patients With Atrial Fibrillation

Delivering on Deadline: Navigating Regulatory Submissions with Pharmacometrics Insights

Establishing Immune Correlates of Protection Against Respiratory Syncytial Virus Infection to Accelerate Vaccine Development: A Model-Based Meta-Analysis

Newsletter sign up

Quick links

Solutions

Contact