title: Simple bioequivalence criteria: are they relevant to critical dose drugs? Experience gained from cyclosporine.
abstract: A critique of the current bioequivalence regulations is presented with reference to critical dose drugs. Using the development of a new cyclosporine formulation as an example, the deficiencies in current bioequivalence testing guidelines are examined and discussed. Based on the experience gained with cyclosporine, recommendations are made on how therapeutic equivalence, rather than just bioequivalence, should be established.
authors.affiliation: St Bartholomew's Hospital, London, U.K.
authors.forename: A
authors.initials: A
authors.lastname: Johnston
authors.forename: P A
authors.initials: PA
authors.lastname: Keown
authors.forename: D W
authors.initials: DW
authors.lastname: Holt
mesh_terms: D019540:Area Under Curve; D002626:Chemistry, Pharmaceutical; D002986:Clinical Trials as Topic; D016572:Cyclosporine / Q000737:chemistry / Q000493:pharmacokinetics*; D018565:Food-Drug Interactions; D017408:Guidelines as Topic; D006801:Humans; D007166:Immunosuppressive Agents / Q000737:chemistry / Q000493:pharmacokinetics*; D013810:Therapeutic Equivalency; D013997:Time Factors; D014180:Transplantation
chemical_list: D007166:Immunosuppressive Agents; D016572:Cyclosporine