Abstract
The aim of the study was to present an example of experimental design application to set up the dissolution test conditions for the two immediaterelease products of levothyroxine sodium (L-Na) with proven bioequivalence: the generic product A and the reference product B [1, 2]. [...]
Highlights
The aim of the study was to present an example of experimental design application to set up the dissolution test conditions for the two immediaterelease products of levothyroxine sodium (L-Na) with proven bioequivalence: the generic product A and the reference product B [1, 2]
The description of the dissolution profiles by using model-independent methods included the calculation of mean dissolution time (MDT) from the in vitro data for both formulations
Dependent variables were set up as a difference between the MDT observed under various experimental conditions for the investigated products (Y1), as well as the difference between MDT and mean absorption time (MAT) for each product
Summary
Application of Experimental Design for Screening Study of Dissolution Test Conditions: Levothyroxine Sodium Immediate-Release Tablets R&D Institute, Galenika ad, Belgrade, Serbia E-mail: ivana_kocic@yahoo.com
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