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It notes no clinically relevant effect on gastric emptying rate at the 2.4 mg dose and no clinically relevant interactions with the oral medications tested

Characterization of the antiviral effect of 2,3-dideoxy-2, 3-didehydro-beta-L-5-fluorocytidine in the duck hepatitis B virus infection model

Committee members frequently questioned whether FDA had applied an overly stringent evidentiary standard for compounded drug substances