Model Informed Drug Development Archives

Blog

5 Clinical Development Challenges Model-Based Meta-Analysis (MBMA) Helps Address

June 30, 2025 Drug development is increasingly defined by its complexity. Teams must navigate rising…

CertaraJune 30, 2025

Case Study

How Model-informed drug development rescue projects from a risky situation

Discover how Certara’s integrated approach to model-informed drug development helps clients navigate regulatory challenges, achieve…

CertaraJune 26, 2025

Publication

Critical Roles for Modeling and Simulation and Real-World Evidence to Inform Challenges in Clinical Trial Diversity Planning

Due to the highly controlled settings of clinical trials, enrolled subjects may not be fully…

Danielle PillsburyJune 19, 2025

Webinar

From Data to Decisions: Real-World Impact of Model-Based Meta-Analysis (MBMA) with GSK and Certara

CertaraJune 18, 2025

Webinar

Modernizing NCA Workflows: The Power of ADNCA for Regulatory-Ready Pharmacokinetic Analysis

Danielle PillsburyJune 11, 2025

Publication

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

On-Demand Webinar

Evolving Regulatory Landscape for Model Informed Drug Development (MIDD): Impact of the Draft ICH M15 Guidance

SVP, PBPK Consultancy Services, Certara SVP, Quantitative Science Services, Certara Sr. Director, Clinical Pharmacology, Certara…

CertaraMay 23, 2025

Press Coverage

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

On-Demand Webinar

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

Video

Blending Science & Impact in Drug Development: Felix Boakye-Agyeman, Vice President of the QSS Division at Certara

CertaraMarch 27, 2025

Model Informed Drug Development