5. REFERENCES USED FOR THE Q4B EVALUATION

5.1 The PDG Stage 5B sign-off document ( Rev .5.2.2 Japanese Pharmacopoeia ( JP ) : 6.10 Dissolution Test as it appears in Supplement I to the JP Fifteenth edition ( September 28 , 2007 , The Ministerial Notification No .316 ) and in the partial revision of the JP 15th edition made official March 31 , 2009 , by the Ministry of Health , Labour and Welfare Ministerial Notification No . 190 .