Introduction: Tacrolimus (TAC) is a typical immunosuppressant that is metabolized by the CYP3A4/CYP3A5 enzyme[1], commonly used in liver transplants to…
Read moreOral: Real-world data (RWD) in pharmacometrics
Overcoming the discrepancies between clinical trials and real-world data of small cell lung cancer chemotherapy. A data-driven approach to learn across real-world evidence studies
Objectives: Since the 21st Century Cures Act in 2015, the potential for translating between real-world data (RWD) and clinical trials…
Read moreVirtual Patient Cohorts using Modeling and Simulation to support drug development in rare diseases
Objectives: Rare diseases affect approximately 350 million people worldwide with only ~5% of diseases having approved treatments. Drug development in…
Read moreStreamlining Clinical Development of C.E.R.A. (Continuous Erythropoietin Receptor Activator) in Pediatric Chronic Kidney Disease Patients by Integration of Clinical Trial and Real-World Data
Background: Methoxy polyethylene glycol‐epoetin beta or continuous erythropoietin receptor activator (C.E.R.A.) is used for the treatment of anemia in adults…
Read moreA disease model for Multiple Myeloma developed using Real World Data and validated on Phase 3 clinical trials
Objectives: Multiple myeloma (MM) is a neoplasm characterized by the proliferation and accumulation of malignant plasma cells. MM remains incurable…
Read more