ICH E7 Studies in support of special populations: geriatrics - Scientific guideline

This document provides guidance on the clinical evaluation of medicinal products in geriatric populations. It gives special consideration to the differences in pharmacokinetic, pharmacodynamic and dose response studies in elderly patients. It also covers drug drug interaction studies. Read together with questions and answers.

Keywords: Older people, geriatrics, elderly, clinical trials

Current effective version

ICH: E 7: Studies in support of special populations: Geriatrics - Step 5

Reference Number: EMA/CHMP/604661/2009