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A comparison of group sequential and fixed sample size designs for bioequivalence trials with highly variable drugs.

Sophie I E KnahlBenjamin LangFrank FleischerMeinhard Kieser
Published in: European journal of clinical pharmacology (2018)
Due to their favorable performance characteristics, two-stage GSDs are an appealing alternative to fixed sample designs when assessing bioequivalence in highly variable drugs.
Keyphrases
  • finite element analysis
  • drug induced