Studies in Support of Special Populations

3. Pharmacodynamic or 'Dose Response' Studies

The number of age-related pharmacodynamic differences (i.e. increased or decreased therapeutic response, or side effects) discovered to date is small. Therefore, there is no need to complete dose response or other pharmacodynamic studies in elderly participants as a routine requirement.

Separate studies are, however, recommended in the following situations:

• Sedative/hypnotic agents and other psychoactive medicines or medicines with important central nervous system (CNS) effects
• Where sub-group comparisons (elderly versus younger) in the Phase II/III clinical trials database show potentially medically significant age-associated differences in the medicine’s effectiveness or adverse reaction profile, not explainable by pharmacokinetic differences.