Regulatory Response to BCS in Japan BCS : 日本における ... - NIHS

Test Medium of Dissolution tests for Minor Changes
in Excipients (Level 2 in USA = Level C in Japan)
U.S.A.
Japan
BCS
For all drugs
Class 1 : 0.1N HCl Multi-media ( pH 1.2,
Class 2 : Compendial medium pH 3-6, pH6.8, Water)
Class 3 : Multi-media (0.1N HCl,
pH 4.5, pH 6.5, pH7.5)
Class 4 : (Human test)
BCS Simplify
dissolution medium
Multiple PHs are necessary
to ensure BE in normal and
achlorhydric subjects and to
check formulation effects