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
Population Pharmacodynamic Modeling of Plozasiran for Treatment of Familial Chylomicronemia Syndrome
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
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
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
The one-trial era: what the FDA’s shift signals for the future of drug development
The FDA is shifting toward approving drugs based on a single pivotal trial supported by…
CertaraMay 6, 2026
Optimize readiness for MHRA-NICE aligned pathway
Achieve HTA and regulatory success in the MHRA–NICE pathway through early evidence alignment.
CertaraMay 1, 2026
Understanding LC/MS/MS
Discover LC/MS/MS applications in therapy development and bioanalytical method development for robust, compliant pharmaceutical research.
Deven Shah, BPharm, PhDMay 1, 2026
Certara Talks – Pivotal Trial Mandate
Explore how the FDA’s shift toward one pivotal trial plus supporting evidence could reshape drug…
CertaraApril 22, 2026
Extending the Value of Antibody–Drug Conjugates: Model-Informed Labeling, Expansion, and Market Access
Learn how model-informed strategies support ADC labeling, dose optimization, and market access through integrated evidence…
CertaraApril 10, 2026
