Pharmacokinetic Analysis BA/BE & FED 1.Plasma/Serum and/or Whole Blood a.Drug level at sampling times b.Pharmacokinetic parameters *AUC 0-t Last quantifiable concentration *AUC 0-inf Infinity *C max Peak concentration T max Time to peak concentration K el Terminal elimination rate constant t 1/2 Elimination half-life CL/F Clearance Vd Volume of Distribution 2.Urine a.Drug level at sampling intervals (Ae) b.Pharmacokinetic parameters Cumulative excretion (*Ae 0-t ) Maximum excretion rate (*R max ) Time to maximum excretion rate (T max ) * = Pivotal Bioequivalence PK Parameter