Drug Development Archives

Announcement

Certara Cuts Pharmacometrics Submission Timelines in Half: New Expedited Service Accelerates Global Regulatory Filings

Certara launches an expedited Pharmacometrics (PMx) Regulatory Submission service that cuts submission timelines in half.

Certara2025 年 12 月 3 日

Publication

Modeling amyloid plaque turnover dynamics improves characterization of drug effects

Researchers modeled how amyloid plaques form and clear in Alzheimer’s disease, helping explain how treatments…

Certara2025 年 11 月 26 日

Guide

10 Strategic Foundations for Early Drug Development

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

Certara2025 年 11 月 26 日

Webinar

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

Certara2025 年 11 月 13 日

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…

Certara2025 年 11 月 12 日

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 Pillsbury2025 年 11 月 12 日

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…

Certara2025 年 11 月 10 日

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…

Certara2025 年 11 月 10 日

Webinar

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

Certara2025 年 11 月 6 日

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…

Certara2025 年 11 月 5 日

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Certara Cuts Pharmacometrics Submission Timelines in Half: New Expedited Service Accelerates Global Regulatory Filings

Modeling amyloid plaque turnover dynamics improves characterization of drug effects

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

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