Therapeutic equivalence investigations: statistical considerations

Stat Med. 1998 Aug;17(15-16):1703-14. doi: 10.1002/(sici)1097-0258(19980815/30)17:15/16<1703::aid-sim972>3.0.co;2-g.

Abstract

Therapeutic equivalence studies still present problems to regulatory reviewers from many perspectives. This paper is intended to discuss some of these concerns from the statistical viewpoint. There are, however, also some newer approaches which may be particularly useful for the investigation of therapeutic equivalence.

Publication types

  • Review

MeSH terms

  • Bias
  • Data Interpretation, Statistical*
  • Drug Evaluation / standards*
  • Guidelines as Topic
  • Humans
  • Placebos
  • Randomized Controlled Trials as Topic / standards*
  • Reproducibility of Results
  • Therapeutic Equivalency*

Substances

  • Placebos