Figure 1. Gender Studies

PK and/or PD gender effects in phase 1 and 2 studies

• Prior information
• Intended use
• Narrow therapeutic index drugs
• Nonclinical studies
• Critical/lifesaving
• Routes of elimination (e.g., 3 A 4)
• Others

Signal of Gender Effect?

If yes:

Targeted PK and/or PD studies to confirm gender effect:

If yes:

Conduct appropriately designed phase 2B/phase 3 clinical trials with appropriate dosing.
(Safety and Efficacy Gender Subset Analyses)

If no:

Conduct ordinary phase 2B/phase 3 clinical trials. No different doses between genders.
v

Signal of Gender Effect?

If no:

Go to phase 2B/phase 3 clinical trials. Do prospectively designed population PK/PD--Gender effect?

If yes:

Unexpected findings.
(Safety and Efficacy Gender Subset Analyses)

If no:

Confirmed.

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