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Clinical& Bioanalytical Investigation Of Drug In Erectile Dysfunction (Paperback)
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Clinical& Bioanalytical Investigation Of Drug In Erectile Dysfunction (Paperback)
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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 increasei
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