title: Therapeutic equivalence investigations: statistical considerations.
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.
authors.affiliation: Federal Institute for Drugs and Medical Devices, Berlin, Germany.
authors.forename: J
authors.initials: J
authors.lastname: Röhmel
mesh_terms: D015982:Bias; D003627:Data Interpretation, Statistical; D004341:Drug Evaluation / Q000592:standards*; D017408:Guidelines as Topic; D006801:Humans; D010919:Placebos; D016032:Randomized Controlled Trials as Topic / Q000592:standards*; D015203:Reproducibility of Results; D013810:Therapeutic Equivalency
chemical_list: D010919:Placebos