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Description of Clinical& Bioanalytical Investigation Of Drug In...
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Erectile dysfunction(impotence)is the inability to get and maintain an erection that is sufficient for satisfactory sexual intercourse.The development and validation of bio-analytical method suitable for the quantification of drugs in biological matrices was assessed.The method was validated over a concentration range of 5.00ng/mlto1491.74 ng/ml for the drug in healthy adult male human subjects under fed and fasting conditions.. This validation report provides the results of selectivity, matrix effect,sensitivity, linearity, calibration curve standards and quality control samples data,precision and accuracy data,goodness of fit.Pharmacokinetic parameters, bioequivalence parameters,stabilities and food effect were obtained following administration of 100 mg oral dose of the drug for both test and reference product. In fed condition drug is absorbed slowly as compared to fasting condition. The test formulation under fed condition is not bioequivalent with reference formulation in terms of Cmax. In the food effect study,foods lower down the rate of the absorption but the extentis similar.It delayed the mean T,produced a small reduction in K and increaseinT1/2.