ICH E7 - Studies in Support of Special Populations: Geriatrics

What it says

E7 gives guidance on including geriatric patients in clinical development programs. It recommends that a fair number of patients aged 65 and over be enrolled in studies, including patients aged 75 and over, and addresses pharmacokinetic considerations, drug interactions, comorbid illness and concomitant treatments that can affect response in older people.

Paraphrased for plain-language clarity. Always verify against the current published regulation text.

What it means in practice

• Older patients often take several medicines, so interaction studies are important.
• Excluding older patients without good reason can leave gaps in the data for those who will use the drug.
• Age-related changes in kidney and liver function may require dose adjustment.

What inspectors look for

• Whether older patients were represented in the studies.
• Whether age-related findings were analyzed.
• Whether exclusions are justified.

Related regulations