Metadata
Author: Giga-fren
Data
English[en]
In the case of delayed-release or other modified-release preparations whose coatings affect drug release, the following conditions apply: 1.2.1 Test Documentation As described in section 1.1.1, with the exception that bioequivalence studies must additionally be undertaken to demonstrate product equivalence.
French[fr]
1.2.2 Niveau de la présentation Un supplément est requis.