高特异性药物的生物等效性研究.ppt

Why Bioequivalence of Highly Variable Drugs is an Issue;Definition of Highly Variable Drugs (HVDs);Current Bioequivalence Criteria;April 14, 2004;Why Alternative Acceptance Criteria Are Needed for HVDs;Foreign BE Criteria;Types of Drugs That Are Highly Variable;Fed BE Studies;Why Current 80-125% Criteria Are Not Appropriate For HVDs;Different HVDs May Require Different Approaches – One Size Does Not Fit All;Example 1: HVDs Not Subject to Significant Accumulation at Steady State;Example 2: HVDs Subject to Significant Accumulation at Steady State;Example 2: HVDs Subject to Significant Accumulation at Steady State (cont’d);April 14, 2004;April 14, 2004;April 14, 2004;April 14, 2004;Special Considerations;Parallel Studies for Long Half-Life Drugs;Pooling Data from Multiple Dosing Groups;Conclusions