The Use of Biomarkers in Human Pharmacology (Phase I) Studies

摘要: The development of a new medicine is risky and costly undertaking that requires careful planning. This planning largely applied to the operational aspects less so scientific objectives methodology. drugs will be developed in future increasingly affect pathophysiological pathways have been unexplored. Such drug prototypes cannot immediately introduced large clinical trials. effects on normal physiology, pathophysiology, eventually desired need evaluated structured approach, based definition as providing answers important questions by appropriate studies. review describes selection process for biomarkers are fit-for-purpose stage which they used. practical approach widely applicable particularly useful early stages innovative development.