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Why You Need an Integrated Development Plan Blog Why You Need an Integrated Development Plan Learn about the Integrated Development Plan for successful drug development & its relation to the…CertaraOctober 17, 2024
Academic Centers of Excellence for Model-informed Drug Development (MIDD) Fact Sheet Academic Centers of Excellence for Model-informed Drug Development (MIDD) CertaraOctober 16, 2024
Medicines in pregnancy: A clinical pharmacology extrapolation framework to address knowledge gaps Publication Medicines in pregnancy: A clinical pharmacology extrapolation framework to address knowledge gaps CertaraOctober 16, 2024
Why cancer drug programs need human mass balance studies Blog Why cancer drug programs need human mass balance studies Historically, drug programs for oncology and other rapidly fatal diseases didn’t include mass balance studies…CertaraSeptember 23, 2024
Resmetirom: A pioneering NASH clinical program Blog Resmetirom: A pioneering NASH clinical program Nonalcoholic fatty liver disease (NAFLD) is a condition wherein the liver stores excess fat. Nonalcoholic…CertaraAugust 23, 2024
Using Quantitative Systems Pharmacology (QSP) Modeling for Oncology Dose Optimization On-Demand Webinar Using Quantitative Systems Pharmacology (QSP) Modeling for Oncology Dose Optimization The FDA’s Project Optimus initiative aims to reform dose optimization and selection for oncology therapies…CertaraAugust 19, 2024
Medicines that matter: Biohaven’s Nurtec™ drug development journey Case Study Medicines that matter: Biohaven’s Nurtec™ drug development journey In February 2020, Biohaven Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) approved…CertaraAugust 15, 2024
Clinical Pharmacology & Model-Informed Drug Development Insights for Targeted Radiation Therapies On-Demand Webinar Clinical Pharmacology & Model-Informed Drug Development Insights for Targeted Radiation Therapies Targeted radiation therapies (TRT) deliver cytotoxic radiation selectively to tumors. In recent years, oncology drug…CertaraMay 22, 2024