Table 1.

Recommended level of evidence needed for implementation of alternative dosing regimens

Type of dosing regimen	Evidence needed for implementation
Equivalent exposure	Exposure within no-effect boundariesa
Lower or shorter exposure	Non-inferiority on efficacy outcomesb
Higher exposure	Non-inferiority on efficacy outcomes compared with standard of care Superiority on efficacy compared with placebo

^aBased on exposure–response analysis or conservative no-effect boundary of 80%-125% on the area under the curve.

^bDefault non-inferiority margin of 20% on clinical outcome.