Articles liés à Clinical& Bioanalytical Investigation Of Drug In...

Clinical& Bioanalytical Investigation Of Drug In Erectile Dysfunction - Couverture souple

Ashwlayan, Vrish Dhwaj; Yadav, Ritu; Sharma, Sandeep

 
9783659294013: Clinical& Bioanalytical Investigation Of Drug In Erectile Dysfunction
Couverture souple
ISBN 10 : 3659294012 ISBN 13 : 9783659294013
Editeur : LAP LAMBERT Academic Publishing, 2012

Synopsis

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.

Les informations fournies dans la section « Synopsis » peuvent faire référence à une autre édition de ce titre.

Présentation de l'éditeur

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.

Biographie de l'auteur

Dr. Vrish Dhwaj Ashwlayan, Associate Professor has 12.5 years[9.5 yrs Academic (5.5 Yrs at U.G. Level and 4 Yrs at P.G. level including research)and 3 years Industrial]Experience.He has guided 20 M.Pharmacy Pharmacology students and published 28 papers in the field of Neuropharmacology,Phytopharmacology,Ethnopharmacology and Clinical Pharmacology.

Les informations fournies dans la section « A propos du livre » peuvent faire référence à une autre édition de ce titre.

Éditeur
LAP LAMBERT Academic Publishing
Date d'édition
2012
Langue
anglais
ISBN 10 
3659294012
ISBN 13 
9783659294013
Reliure
Broché
Nombre de pages
132
Coordonnées du fabricant
non disponible
Personne responsable
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