Progress and review requirement for Aripiprazole Tablet bioequivalence test in China
Aripiprazole tablet is used for the treatment of schizophrenia,which is a common drug for psychiatric diseases in clinic.Combined with the United States and China Aripiprazole Tablet bioequivalence test guidelines requires,summary and analysis based on recent years bioequivalence result in China,and propose general review requirements for Aripiprazole Tablet bioequivalence test.Generally,about 36 healthy subjects over 45 years of age should be selected for fasting and fed bioequivalence of Aripiprazole Tablets.For safety reasons,10mg was used to carry out related studies,and health monitoring of subjects should be done during the bioequivalence.In terms of pharmacokinetic parameters,AUC truncated to 72 hours can be used instead of AUC0~tor AUC0~inf for statistical analysis of bioequivalence,and there should be suffiicient long cleaning period during the two-week period.In addition to the above requirements,for aripiprazole orally disintegrating tablets should be administered without water.