Small Biotech Clinical Trial Application (CTA) & Investigational New Drug (IND) Submission Success with Integrated Project Management
Find out how Certara helped a small biotech achieve on-time IND and CTA submissions with…
CertaraAugust 18, 2025
Population Pharmacokinetics for Belantamab Mafodotin Monotherapy and Combination Therapies in Patients with Relapsed/Refractory Multiple Myeloma
Explore comprehensive population pharmacokinetic analyses of belantamab mafodotin, evaluating both monotherapy and combination regimens in…
CertaraAugust 13, 2025
Sacituzumab Govitecan Population Pharmacokinetics: Updated Analyses Using HR+/HER2− Metastatic Breast Cancer Data From the Phase 3 TROPiCS‐02 Trial
Explore updated results from the Phase 3 TROPiCS-02 trial of Sacituzumab Govitecan in advanced HR+/HER2–…
CertaraAugust 13, 2025
Replacing Traditional TQT Studies with Model-Based Concentration-QTc (C-QTc) Analysis for Cardiovascular Safety in Drug Development
Learn how our experts use concentration-QTc (C-QTc) analysis to replace costly TQT studies, streamline QT…
CertaraAugust 6, 2025
ADNCA Explained: The Next Generation of Non-Compartmental Analysis and the Top Questions Answered
ADNCA is transforming non-compartmental analysis by standardizing workflows, enhancing regulatory confidence, and enabling scalable automation.…
CertaraJuly 23, 2025
Accelerating Oncology Drug FDA RTOR Submission with Project Management Services
Discover how Certara’s dedicated project management and pharmacometric support helped an emerging biotech company fast-track…
CertaraJuly 2, 2025
The Medicine Maker: The Biosimulation Generation
The article, The Biosimulation Generation, explores the transformative potential of biosimulation in pharmaceutical R&D as…
Danielle PillsburyJuly 1, 2025
