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[Comparative clinical study of two dexamethasone phosphate-containing ophthalmics]

Author(s): Gross D, Struck HG

Affiliation(s): URSAPHARM Arzneimittel GmbH & Co. KG, Industriestrasse 35, 66129 Saarbrucken, Germany. d.gross@ursapharm.de

Publication date & source: 2007, Arzneimittelforschung., 57(5):254-9.

Publication type: Comparative Study; English Abstract; Multicenter Study; Randomized Controlled Trial

For the drug application of the already known active ingredient dexamethasone dihydrogen phosphate disodium salt (CAS 2392-39-4) for ocular use clinical data on the efficacy and safety were required by the drug regulatory agency. The comparison of the pharmaceutical properties had already shown that no differences in clinical use had to be expected. The results of a double-blind, randomised, comparative clinical study on 210 patients prove that no differences between test and comparator product could be observed. This case shows that the demand for clinical trials to proof therapeutic equivalence should be done with a sense of proportion related to the specific situation.

Page last updated: 2007-08-04

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