9783848438143 - bioanalytical method validation: bio-products validation technique di waghulkar ( thakare), vijay m.; deshpande, supriya s.; rathod, pandurang r. (3 risultati)
Bioanalytical Method Validation: Bio-Products Validation Technique
Waghulkar ( Thakare), Vijay M., Deshpande, Supriya S., Ratho
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Bioanalytical Method Validation
Vijay M. Waghulkar ( Thakare)|Supriya S. Deshpande|Pandurang R. Rathod
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Kartoniert / Broschiert. Condizione: New. Dieser Artikel ist ein Print on Demand Artikel und wird nach Ihrer Bestellung fuer Sie gedruckt. Autor/Autorin: Waghulkar ( Thakare) Vijay M.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 Re…search Fellow(Ph.D.)in S.G.B.Amravati University, Presen.
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Da: AHA-BUCH GmbH, Einbeck, GermaniaAHA-BUCH GmbH
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Taschenbuch. Condizione: Neu. nach der Bestellung gedruckt Neuware - Printed after ordering - 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 det…ermination 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.
