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The fundamental pK parameters of test articles after IV (t 1/2 , C 0 , AUC last , AUC inf , AUC/D, AUC extr , MRT, Vss and CL) administration were obtained from the non-compartmental analysis (NCA) of the plasma data using WinNonlin

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As there is no private right of action, theories of liability that rely on FDCA violations are commonly preempted, Deshmukh said