Blog

Beyond Compliance: What ICH M15 Means for the Future of Drug Development

Explore how ICH M15 is shaping regulatory expectations for Model-Informed Drug Development (MIDD), including model…

CertaraJune 9, 2026

Press Coverage

The Case for Simulating Pregnancy

Pregnant women are routinely excluded from drug trials, leaving clinicians without dosing guidance. Discover how…

CertaraJune 9, 2026

Case Study

Model-Informed Development Accelerates Transformative Treatment for Sleeping Sickness

Certara’s drug development support enabled a positive scientific opinion from the EMA for acoziborole, a…

CertaraJune 2, 2026

Webinar

Model Acceptance in Regulatory Submissions: Practical Strategies for Regulatory Success

CertaraJune 1, 2026

Publication

Oxford Academic, Neuro-Oncology Pediatrics – BRAF pub: Growth recovery in patients with BRAF-altered pediatric low-grade glioma following treatment with tovorafenib

This publication reports a pooled retrospective analysis evaluating growth patterns in children with B-Raf proto-oncogene…

Dorottya Gui-BodnarMay 28, 2026

Publication

Population Pharmacokinetic Modeling of Niraparib to Assess Different Absorption Models

This publication describes the development of an updated population pharmacokinetic (PopPK) model for niraparib, a…

CertaraMay 21, 2026

Blog

Best Practices for pharma commercialization in market access

Learn best practices for your pharma commercialization strategy. See how to localize content in pharma…

Daria LavrentevMay 12, 2026

On-Demand Webinar

BioSpace webinar: Streamlining Nonclinical Development with FDA NAMs

Learn how to apply FDA NAM guidance to streamline nonclinical development, support IND decisions, and…

CertaraMay 8, 2026

Guide

Designing Drug Development Programs for Reimbursement Success

Download the guide to learn how model-informed drug development, QSP, and MBMA help align with…

CertaraMay 7, 2026

Publication

Population Pharmacodynamic Modeling of Plozasiran for Treatment of Familial Chylomicronemia Syndrome

A newly approved RNA interference (RNAi) therapy lowers harmful triglyceride (TG) levels in patients with…

CertaraMay 7, 2026

Certara Services

Beyond Compliance: What ICH M15 Means for the Future of Drug Development

The Case for Simulating Pregnancy

Model-Informed Development Accelerates Transformative Treatment for Sleeping Sickness

Model Acceptance in Regulatory Submissions: Practical Strategies for Regulatory Success

Oxford Academic, Neuro-Oncology Pediatrics – BRAF pub: Growth recovery in patients with BRAF-altered pediatric low-grade glioma following treatment with tovorafenib

Population Pharmacokinetic Modeling of Niraparib to Assess Different Absorption Models

Best Practices for pharma commercialization in market access

BioSpace webinar: Streamlining Nonclinical Development with FDA NAMs

Designing Drug Development Programs for Reimbursement Success

Population Pharmacodynamic Modeling of Plozasiran for Treatment of Familial Chylomicronemia Syndrome

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