Drug Development Archives

Case Study

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

Conference

BioTechX US 2025

– – Booth

Simona ColucciAugust 15, 2025

Publication

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

Publication

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

Announcement

Certara Announces D360 25.5 Release, Featuring Dynamic Data Subsets and Enhanced Analytics

D360 v25.5 allows scientists to divide up a dataset into series of compounds & perform…

CertaraAugust 7, 2025

On-Demand Webinar

De-risking DDI Management during Clinical Trials: Introducing DIDB’s Concomitant Meds Navigator

Watch the on-demand presentation covering how the DIDB® Concomitant Meds Navigator empowers clinical development teams…

CertaraAugust 5, 2025

On-Demand Webinar

Understanding Antibody-Drug Conjugates (ADCs) Pharmacokinetics From NCA to Population PK Approaches

CertaraAugust 1, 2025

Blog

Machine Learning (ML) in healthcare

Learn about 3 distinct examples of machine learning (ML) in healthcare that utilize different techniques…

CertaraAugust 1, 2025

Blog

Model-Based Meta-Analysis (MBMA) at GSK: Real-World Impact on Strategy and Trials

GSK shares real-world case studies on how Model-Based Meta-Analysis (MBMA) supports dose selection, virtual control…

CertaraJuly 31, 2025

Case Study

Optimizing Dosing and Regulatory Outcomes in Duchenne Muscular Dystrophy (DMD) Drug Development

Certara supported DMD drug development for Givinostat, helping Italfarmaco with pharmacometric and regulatory strategy.

CertaraJuly 29, 2025

Drug Development