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
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
Translational Pharmacology Consulting Supports Combination Therapy for Treating Pulmonary Mycobacterium Avium Complex Disease
RedHill Biopharma Ltd., a specialty biopharmaceutical company, developed RHB-204, a treatment for MAC, and needed…
Certara2023年5月9日
Therapeutic Proteins’ Drug-Drug Interactions: Updates & Challenges
Therapeutic proteins (TP) - and more specifically monoclonal antibodies - are part of the therapeutic…
Certara2022年12月5日
