Tag: dose

How to successfully develop and validate molecular biomarkers for use in clinical trials

Diana Nijholt, Consultant Translational & Clinical Development

Introduction In our previous blog entitled ‘Biomarkers in early development‘, we highlighted the different types of biomarkers and their applications in (early) drug development. We discussed that biomarkers have the potential to speed up and enhance the chances of success of a clinical development program. A biomarker can, for example, define a patient subset most continue reading…

What is the Right Dose for Patients: An Introduction for Laymen

What is the right dose for patients

Introduction In my role as a consultant and in conversations with individuals who have limited experience in clinical drug development, I often find that there is some confusion between the terms “dose” and “exposure” (the plasma or local concentration of a drug). While these terms are related, they refer to distinct concepts, and understanding the continue reading…