Studies in Support of Special Populations

Some groups in the general population may require special study. This may be because they have unique risk-benefit considerations that need to be taken into account during medicines development, or because it can be anticipated their use of the dose or schedule will need to be modified.

Medicines should be studied in all age groups for which they will have significant use. Patients who participate in clinical trials should be reasonably representative of the population that will be later treated by the medicine.

In these studies, it also should be considered to obtain pharmacokinetic information (i.e. what the body does to the medicine (ADME) in the following sub-populations:

• patients with impaired excretion – i.e. those who may have difficulty removing the medicine from their body due to kidney or liver problems
• the elderly
• children
• women
• ethnic sub-groups.

Non-clinical safety studies should support human clinical trials in special populations – i.e. the special populations should be replicated in animal studies before human studies are carried out.