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…
Certara2025 年 8 月 18 日
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…
Certara2025 年 8 月 13 日
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–…
Certara2025 年 8 月 13 日
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…
Certara2025 年 8 月 6 日
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.…
Certara2025 年 7 月 23 日
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…
Certara2025 年 7 月 2 日
The Medicine Maker: The Biosimulation Generation
The article, The Biosimulation Generation, explores the transformative potential of biosimulation in pharmaceutical R&D as…
Danielle Pillsbury2025 年 7 月 1 日
