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What Category 2 was, and why removal matters The FDAs 503A bulk drug substances framework is a three-bucket system

Mol Cell 2012;47:349-58

In agreement with these in vitro findings, the intestinal protein expression of CYP3A4 did not differ between guinea-pigs fed RRR-T at normal dietary (20 mg/kg diet) or pharmacological doses (250 mg/kg diet) for 6 weeks ( Reference Podszun, Grebenstein and Hofmann 37 )