| Literature DB >> 9263375 |
A Johnston1, P A Keown, D W Holt.
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.Entities:
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Year: 1997 PMID： 9263375 DOI： 10.1097/00007691-199708000-00002
Source DB: PubMed Journal: Ther Drug Monit ISSN： 0163-4356 Impact factor: 3.681