Machine Learning for PK/PD Modeling in Drug Development Blog Machine Learning for PK/PD Modeling in Drug Development Pharmacometricians can use machine learning for PK/PD modeling to help them characterize the safety and…CertaraMarch 4, 2025
How the US FDA MIDD paired pilot program helps sponsors Blog How the US FDA MIDD paired pilot program helps sponsors February 28, 2025 For the past couple of decades, leading American institutions, pharmaceutical and biotechnology…CertaraFebruary 28, 2025
Measuring metabolites in index clinical DDI studies Blog Measuring metabolites in index clinical DDI studies February 7, 2025A key drug development safety consideration is whether the drug candidate will interact…CertaraFebruary 7, 2025
Why FDA’s omaveloxolone approval for Friedreich’s ataxia matters Blog Why FDA’s omaveloxolone approval for Friedreich’s ataxia matters January 10, 2025 Friedreich’s Ataxia (FA) is a rare, genetic, and progressive neurodegenerative disorder. A…CertaraJanuary 10, 2025
Key development considerations for cell therapies Blog Key development considerations for cell therapies December 5, 2024 What is a “cell therapy”? Nearly every recent oncology clinical conference has…CertaraDecember 5, 2024
De-risking Drug Development: Key Chemistry, Manufacturing, and Controls (CMC) and Physiologically Based Pharmacokinetic (PBPK) Approaches in Early Development Blog De-risking Drug Development: Key Chemistry, Manufacturing, and Controls (CMC) and Physiologically Based Pharmacokinetic (PBPK) Approaches in Early Development November 22, 2024 In drug development, early strategic planning is crucial to minimizing risks, optimizing…CertaraNovember 22, 2024
Shining a spotlight on Clinical Study Software at the 2024 Pinnacle 21 Enterprise User Group Meeting Blog Shining a spotlight on Clinical Study Software at the 2024 Pinnacle 21 Enterprise User Group Meeting On October 30, 2024, we hosted our Pinnacle 21 Enterprise (P21E) User Group Meeting (UGM)…CertaraNovember 12, 2024
Why Clinical Pharmacology & Pharmacometrics Should Collaborate Blog Why Clinical Pharmacology & Pharmacometrics Should Collaborate A symbiosis between a modeler and a trialist is often required to develop a model-informed…CertaraNovember 8, 2024