Pharmacometrics Archives

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

Blog

Key Lessons & Opportunities in applying NCA and PopPK to ADCs

Applying NCA and PopPK to ADCs helps decode complex PK, balance DAR effects, and guide…

CertaraOctober 24, 2025

Blog

Essentials of Model-informed Drug Development in Oncology

Model-informed drug development in oncology is critical to developing safer and more effective cancer drugs.…

CertaraOctober 6, 2025

Blog

Redefining Regulatory Strategy with MIDD: Insights from the Draft ICH M15 Guidance

With the release of the draft ICH M15 guidance, MIDD is no longer optional -…

CertaraJune 11, 2025

On-Demand Webinar

Streamlining Population PK Modeling with Phoenix NLME & Pirana: Bridging Efficiency and Precision in Pharmacometrics [APAC Webinar]

Senior Director, Pharmacometric Software, Certara Keith has more than 20 years of global drug development…

CertaraApril 24, 2025

Publication

Safety of combined long-acting injectable cabotegravir and long-acting injectable rilpivirine in virologically suppressed adolescents with HIV (IMPAACT 2017/MOCHA): a phase 1/2, multicentre, open-label, non-comparative, dose-finding study

The IMPAACT 2017/MOCHA study, a phase 1/2 multicenter trial across five countries, assessed the safety,…

CertaraMarch 20, 2025

Publication

The Unrealized Potential of Advanced Modeling Methods to Inform Early Strategic Planning for Payer Reimbursement

This article explores the overlooked yet critical role of early strategic planning for payer reimbursement…

CertaraFebruary 25, 2025

Video

Certara’s Phoenix Platform – The world’s most trusted platform for PK/PD analysis and modeling

Today’s drug candidates are more complex than ever. But with development decisions on the line,…

CertaraFebruary 12, 2025

Pharmacometrics

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

Key Lessons & Opportunities in applying NCA and PopPK to ADCs

Essentials of Model-informed Drug Development in Oncology

Redefining Regulatory Strategy with MIDD: Insights from the Draft ICH M15 Guidance

Streamlining Population PK Modeling with Phoenix NLME & Pirana: Bridging Efficiency and Precision in Pharmacometrics [APAC Webinar]

Safety of combined long-acting injectable cabotegravir and long-acting injectable rilpivirine in virologically suppressed adolescents with HIV (IMPAACT 2017/MOCHA): a phase 1/2, multicentre, open-label, non-comparative, dose-finding study

The Unrealized Potential of Advanced Modeling Methods to Inform Early Strategic Planning for Payer Reimbursement

Certara’s Phoenix Platform – The world’s most trusted platform for PK/PD analysis and modeling

Newsletter sign up

Quick links

Solutions

Contact