Assessment of the Effects of Fruquintinib on Cardiac Safety in Patients with Metastatic Colorectal Cancer
The study, published in the Journal of Clinical Pharmacology, evaluates the cardiac safety of fruquintinib,…
CertaraJune 8, 2025
Evolving Regulatory Landscape for Model Informed Drug Development (MIDD): Impact of the Draft ICH M15 Guidance
We explore the evolving regulatory landscape for Model-Informed Drug Development (MIDD), focusing on the impact…
CertaraMay 23, 2025
Explore First: How a Stepwise Approach to QTc Studies Reduces Time, Cost, and Regulatory Risk
Learn how a stepwise C-QTc approach can streamline cardiac safety evaluation, reduce costs, and align…
CertaraMay 5, 2025
FDA plans to phase out animal testing requirements
Discover how the FDA plans to replace animal testing with AI and organ-on-chip technologies for…
CertaraApril 10, 2025
MIDD’s Growing Role in Global Health: A Case Study of Primaquine Exposures in Lactating Women and Breastfed Infants
Explore how model-informed drug development (MIDD) enhanced clinical lactation studies and supported global health policy…
CertaraMarch 28, 2025
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CertaraMarch 27, 2025
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CertaraMarch 26, 2025
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CertaraMarch 26, 2025
