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
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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
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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
Reflections on the New FDA Clinical Pharmacology Guidance for Antibody-Drug Conjugates Blog Reflections on the New FDA Clinical Pharmacology Guidance for Antibody-Drug Conjugates In recent years, oncology drug developers have invested in antibody-drug conjugates (ADCs). These targeted therapies…CertaraMay 10, 2024
Modeling and simulation in pediatric drug development Press Coverage Modeling and simulation in pediatric drug development Published: December 21, 2023 This is the article written in German, published on pharmind. Children's…CertaraDecember 21, 2023