Topic: Regulatory Framework for Equivalence

The All-Criteria Rule for Multiple Primary Endpoints

The Conventional 80–125% Acceptance Limits

The Role of Tmax and Supportive Endpoints

Selecting the Correct Reference Product and Comparator

Regulatory Handling of Multiple Strengths and Strength Waivers

Regulatory Use of Partial AUC Criteria

Product-Specific Guidance and Tailored BE Criteria

Interpreting Upper and Lower Limits on the Ratio Scale

Interpreting Borderline and Failed BE Decisions

How Regulatory Margins Are Chosen and Prespecified