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
Academic Centers of Excellence for Model-informed Drug Development (MIDD)
Danielle Pillsbury2024 年 10 月 16 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…
Danielle Pillsbury2024 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…
webdev2024 年 8 月 15 日
Clinical Pharmacology & Model-Informed Drug Development Insights for Targeted Radiation Therapies
靶向放射性核素治疗（TRT）通过将细胞毒性辐射选择性作用于肿瘤实现精准治疗。In recent years, oncology drug…
Danielle Pillsbury2024 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
Modeling and simulation in pediatric drug development
Published: 2023 年 12 月 21 日 This is the article written in German, published on pharmind.Children's…
Certara2023 年 12 月 21 日
