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

Publisher: 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.

About this title

About the Author

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.

Edition details

• Publisher: LAP LAMBERT Academic Publishing
• Publication date: 2012
• Language: English
• ISBN 10: 3848438143
• ISBN 13: 9783848438143
• Binding: Paperback
• Number of pages: 68