Bioanalytical Method Validation: Bio-Products Validation Technique - Couverture souple

Waghulkar ( Thakare), Vijay M.; Deshpande, Supriya S.; Rathod, Pandurang R.

 
9783848438143: Bioanalytical Method Validation: Bio-Products Validation Technique
Couverture souple
ISBN 10 : 3848438143 ISBN 13 : 9783848438143
Editeur : LAP LAMBERT Academic Publishing, 2012

Synopsis

The development of sound bioanalytical method(s) is of paramount importance during the process of drug discovery and development culminating in a marketing approval.Bioanalytical method validation (BMV) employed for the quantitative determination of drugs and their metabolites in biological fluids plays a significant role in the evaluation and interpretation of bioavailability, bioequivalence, pharmacokinetic, and toxicokinetic study data. These studies generally support regulatory filings. It has been adopted universally as a standard procedure for validating bioanalytical assays used for pharmacokinetic, bioavailability, and bioequivalence studies intended for regulatory submission.The objective of this BMV is to review the sample preparation of drug in biological matrix and to provide practical approaches for determining selectivity, specificity, limit of detection, lower limit of quantitation, linearity, range, accuracy, precision, recovery, stability, ruggedness, and robustness of liquid chromatographic methods to support pharmacokinetic, toxicokinetic, bioavailability, and bioequivalence studies.

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

Présentation de l'éditeur

The development of sound bioanalytical method(s) is of paramount importance during the process of drug discovery and development culminating in a marketing approval.Bioanalytical method validation (BMV) employed for the quantitative determination of drugs and their metabolites in biological fluids plays a significant role in the evaluation and interpretation of bioavailability, bioequivalence, pharmacokinetic, and toxicokinetic study data. These studies generally support regulatory filings. It has been adopted universally as a standard procedure for validating bioanalytical assays used for pharmacokinetic, bioavailability, and bioequivalence studies intended for regulatory submission.The objective of this BMV is to review the sample preparation of drug in biological matrix and to provide practical approaches for determining selectivity, specificity, limit of detection, lower limit of quantitation, linearity, range, accuracy, precision, recovery, stability, ruggedness, and robustness of liquid chromatographic methods to support pharmacokinetic, toxicokinetic, bioavailability, and bioequivalence studies.

Biographie de l'auteur

Vijay Madhukarrao Waghulkar (Thakare)is B.Pharma., M.Pharma.in Quality Assurance from R.S.T.M.Nagpur University,D.B.M. From AIIMS Chennai, He is Research Fellow(Ph.D.)in S.G.B.Amravati University, Presently working as Assistant professor in Q.A. Dept.Vidyabharti College of Pharmacy,Amravati ,He is author of three books in pharmacy.

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 
3848438143
ISBN 13 
9783848438143
Reliure
Broché
Nombre de pages
68
Coordonnées du fabricant
non disponible
Personne responsable
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