Why You Need an Integrated Development Plan
Learn about the Integrated Development Plan for successful drug development & its relation to the…
Certara2024年10月17日
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…
Certara2024年9月23日
Resmetirom: A pioneering NASH clinical program
Nonalcoholic fatty liver disease (NAFLD) is a condition wherein the liver stores excess fat. Nonalcoholic…
Certara2024年8月23日
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…
Certara2024年8月19日
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…
Certara2024年8月15日
Clinical Pharmacology & Model-Informed Drug Development Insights for Targeted Radiation Therapies
標的放射線治療（TRT）は、腫瘍に対して選択的に細胞毒性のある放射線を届けます。In recent years, oncology drug…
Certara2024年5月22日
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…
Certara2024年5月10日
