Drug Development Archives

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

Webinar

The Modeling Advantage: How Forward-Thinking Sponsors Are Moving Faster, De-Risking Earlier, and Winning with Regulators

CertaraMay 26, 2026

Blog

Certainty US 2026 recap: advancing model-informed drug development right from the start

This blog shares the highlights of our US Certainty event and explains how AI-enabled approaches…

CertaraMay 26, 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

Webinar

BioSpace webinar: Streamlining Nonclinical Development with FDA NAMs

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

Publication

Population Pharmacokinetics and Exposure-Response Analysis of Ziftomenib in Relapsed or Refractory Acute Myeloid Leukemia Patients With NPM1 Mutation

This study evaluated how the leukemia drug ziftomenib behaves in the body and whether different…

CertaraMay 7, 2026

Publication

Population Pharmacokinetic Modeling and Exposure-Response Analyses of Nemtabrutinib in Patients With Hematologic Malignancies

Population pharmacokinetic (PopPK) and exposure-response modeling were used to support the clinical development of nemtabrutinib,…

CertaraMay 7, 2026

Blog

Optimize Readiness for MHRA-NICE Aligned Pathway

Achieve HTA and regulatory success in the MHRA–NICE pathway through early evidence alignment.

CertaraMay 1, 2026

Drug Development

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

The Modeling Advantage: How Forward-Thinking Sponsors Are Moving Faster, De-Risking Earlier, and Winning with Regulators

Certainty US 2026 recap: advancing model-informed drug development right from the start

Population Pharmacokinetic Modeling of Niraparib to Assess Different Absorption Models

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

Population Pharmacokinetics and Exposure-Response Analysis of Ziftomenib in Relapsed or Refractory Acute Myeloid Leukemia Patients With NPM1 Mutation

Population Pharmacokinetic Modeling and Exposure-Response Analyses of Nemtabrutinib in Patients With Hematologic Malignancies

Optimize Readiness for MHRA-NICE Aligned Pathway

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