Hypothesis: a single clinical trial plus causal evidence of effectiveness is sufficient for drug approval

Clin Pharmacol Ther. 2003 Jun;73(6):481-90. doi: 10.1016/S0009-9236(03)00018-3.
No abstract available

Publication types

  • Review

MeSH terms

  • Biomarkers
  • Clinical Trials as Topic* / statistics & numerical data
  • Drug Approval / methods*
  • Humans
  • Legislation, Drug / trends*
  • Randomized Controlled Trials as Topic / statistics & numerical data
  • United States
  • United States Food and Drug Administration

Substances

  • Biomarkers