Progress and review requirement for Quetiapine Fumarate Tablet bioequivalence test in China
Quetiapine Fumarate Tablet is used for the treatment of schizophrenia,which is a common drug for psychiatric diseases in clinic.Combined with the FDA and NMPA Quetiapine Fumarate Tablet bioequivalence test guidelines requires,based on recent years bioequivalence results summary and analysis in China,general review requirements was proposed for Quetiapine Fumarate Tablet bioequivalence test.It is recommended to use a two-agent,two-way,two-sequence crossover design to carry out fasting and fed human bioequivalence studies of single-dose,and also to use partial or complete repeat crossover design.Generally,36 to 45 healthy subjects should be selected for fasting and fed bioequivalence of Quetiapine Fumarate Tablets,or to use partial or complete repeat crossover study design.For safety reasons,small strengths were used to related studies,and health monitoring of subjects should be done during the bioequivalence study.The average bioequivalence or the reference-scaled average bioequivalence method may be used for evaluation,and it is recommended that the applicant submit the non-parametric tmax test results of test and reference drug.
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