Simple Bioequivalence Criteria
- 1 August 1997
- journal article
- Published by Wolters Kluwer Health in Therapeutic Drug Monitoring
- Vol. 19 (4) , 375-381
- https://doi.org/10.1097/00007691-199708000-00002
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.Keywords
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