The FDA requires stricter bioequivalence standards for Narrow Therapeutic Index (NTI) drugs like warfarin and phenytoin, using tighter 90-111% limits and replicate studies to ensure safety. These rules prevent dangerous fluctuations in blood levels that can occur with standard generic substitutions.
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Pharmacists play a critical role in catching unsafe generic medications. Learn when to flag problematic generics-especially for narrow therapeutic index drugs, look-alike names, and complex formulations-based on real data and expert guidelines.
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