In Brief: Clozapine bioequivalence studies
Executive Summary
Clozapine bioequivalence studies: FDA will issue a guidance on in vivo bioequivalence studies of the antipsychotic agent clozapine (Sandoz' Clozaril) "within the next few months," agency tells industry in Jan. 31 letter. "If you plan on initiating a clozapine bioequivalence study before this guidance is issued, we encourage you to work with the appropriate institutional review board in selecting the study population to be employed," FDA says. The letter follows reports to FDA of increased side effects seen with clozapine formulations administered to healthy volunteers compared to those seen in the schizophrenic population. At least one generic company, Zenith, has suspended its bio studies of clozapine after side effects in healthy volunteers...
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Clozapine bioequivalence studies: FDA will issue a guidance on in vivo bioequivalence studies of the antipsychotic agent clozapine (Sandoz' Clozaril) "within the next few months," agency tells industry in Jan. 31 letter. "If you plan on initiating a clozapine bioequivalence study before this guidance is issued, we encourage you to work with the appropriate institutional review board in selecting the study population to be employed," FDA says. The letter follows reports to FDA of increased side effects seen with clozapine formulations administered to healthy volunteers compared to those seen in the schizophrenic population. At least one generic company, Zenith, has suspended its bio studies of clozapine after side effects in healthy volunteers.... |