Therapeutic Index · Pharmacology

In which phase of drug development is therapeutic index primarily determined?

  1. Phase I clinical trials
  2. Preclinical animal studies
  3. Phase III clinical trials
  4. Post-marketing surveillance
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Correct answer: Preclinical animal studies

Therapeutic index is primarily determined in preclinical animal studies using LD50 and ED50 values. These experiments establish the safety margin before human trials begin. Clinical trials further assess safety but do not rely on LD50 measurements.

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