Why You Need an Integrated Development Plan
Learn about the Integrated Development Plan for successful drug development & its relation to the…
CertaraOctober 17, 2024
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
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
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
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
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
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
Published: December 21, 2023 This is the article written in German, published on pharmind. Children's…
CertaraDecember 21, 2023
