Bioanalytical Method Validation: Bio-Products Validation Technique - Softcover

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

Softcover

ISBN 10: 3848438143 ISBN 13: 9783848438143

Verlag: LAP LAMBERT Academic Publishing, 2012

Inhaltsangabe

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.

Details zur Ausgabe

• Verlag: LAP LAMBERT Academic Publishing
• Erscheinungsdatum: 2012
• Sprache: Englisch
• ISBN 10: 3848438143
• ISBN 13: 9783848438143
• Einband: Taschenbuch
• Anzahl der Seiten: 68
• Kontakt zum Hersteller: Nicht verfügbar
• Verantwortliche Person: Editions Muse; customerservice@vdm-vsg.de; ; Brivibas gatve 197; Riga; 1039; Lettland