Wyoming MPJE (Pharmacy Jurisprudence) Practice Exam

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For drugs with a narrow therapeutic index, what variability of the original brand product does the FDA require for generic products?

  1. 75-85%

  2. 80-90%

  3. 90-110%

  4. 95-105%

The correct answer is: 75-85%

For drugs with a narrow therapeutic index, the FDA requires generic products to have a variability of 75-85% compared to the original brand product. This tight range is crucial for drugs with narrow therapeutic indices to ensure consistent therapeutic effects and avoid potential adverse reactions due to dose variability. Options B, C, and D provide wider ranges that are not precise enough for drugs with a narrow therapeutic index as required by the FDA.

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