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Bioequivalence studies for generic clozapine (Novartis' Clozaril) products should not be conducted using healthy subjects due to potential for hypotensive effects, FDA says in 1draft guidance posted Dec. 29. Agency also recommends multiple-dose BE studies using the highest dosages instead of a 12.5 mg dose. The document revises a November 1996 guidance (2"The Pink Sheet" Nov. 26, 1996, T&G-14)...
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