Bioanalytical Method Validation (BMV)
C. T. Viswanathan, Surendra Bansal, Brian Booth, Anthony J. DeStefano, Mark J. Rose, et.al.
Workshop/Conference Report - Quantitative Bioanalytical Methods Validation and Implementation: Best Practices for Chromatographic and Ligand Binding Assays
The AAPS Journal 9(1), E30-E42 (2007)
Vinod P. Shah
The History of Bioanalytical Method Validation and Regulation: Evolution of a Guidance Document on Bioanalytical Methods Validation
The AAPS Journal 9(1), E43 - E47 (2007)
C. T. Viswanathan, Surendra Bansal, Brian Booth, Anthony J. DeStefano, Mark J. Rose, et.al.
Quantitative Bioanalytical Methods Validation and Implementation: Best Practices for Chromatographic and Ligand Binding Assays
Pharmaceutical Research 24(10), 1962-1973 (2007)
Vinod P. Shah, Kamal K. Midha, Shrikant Dighe, Iain J. McGilveray, Jerome P. Skelly, et.al.
Analytical methods validation: bioavailability, bioequivalence and pharmacokinetic studies.
Pharmaceutical Research 9(4), 588-592 (1992)
Douglas Fast, Marian Kelley, C. Viswanathan, Jacqueline O'Shaughnessy, S. King, et. al.
Workshop Report and Follow-Up-AAPS Workshop on Current Topics in GLP Bioanalysis: Assay Reproducibility for Incurred Samples-Implications of Crystal City Recommendations
The AAPS Journal 11(2), 238-241 (2009)
Philip Timmerman, Silke Luedtke, Peter van Amsterdam, Margarete Brudny-Kloeppel, Berthold Lausecker
Incurred sample reproducibility: views and recommendations by the European Bioanalysis Forum
Bioanalysis 1(6), 1049-1056 (2009)
Vinod P. Shah, Kamal K. Midha, John W. A. Findlay, Howard M. Hill, James D. Hulse, Iain J. McGilveray, et.al.
Bioanalytical method validation - a revisit with a decade of progress.
Pharmaceutical Research 17(12), 1551-1557 (2000)
BMV Biomarkers
Jean W. Lee, Viswanath Devanarayan, Yu Chen Barrett, Russell Weiner, John Allinson, et.al.
Fit-for-Purpose Method Development and Validation for Successful Biomarker Measurement
Pharmaceutical Research 23(2), 312-328 (2006)
BMV Macromolecules
Marian Kelly and Binodh DeSilva
Key elements of bioanalytical method validation for macromolecules
The AAPS Journal 9(2), E156-E163 (2007)
JoMarie Smolec, Binodh DeSilva, Wendell Smith, Russell Weiner, Marian Kelly, et.al
Bioanalytical Method Validation for Macromolecules in Support of Pharmacokinetic Studies
Pharmaceutical Research 22(9), 1425-1439 (2005)
Krys J. Miller, Ronald R. Bowsher, Abbie Celniker, Jacqueline Gibbons, Shalini Gupta, et.al.
Workshop on Bioanalytical Methods Validation for Macromolecules: Summary Report
Pharmaceutical Research 18(9), 1373-1383 (2001)
Findlay JW, Smith WC, Jean W Lee, Nordblom GD, Das I, et.al.
Validation of immunoassays for bioanalysis: a pharmaceutical industry perspective.
J of Pharm Biomed Anal. 21(6), 1249-1273 (2000)
Binodh DeSilva, W Smith, Russel Weiner, Marian Kelley, JoMarie Smolec, et.al.
Recommendations for the Bioanalytical Method Validation of Ligand-Binding Assays to Support Pharmacokinetic Assessments of Macromolecules
Pharmaceutical Research 20 (11), 1885-1900 (2003)
Immunogenicity
Gopi Shankar, Viswanath Devanarayan, Lakshmi Amaravadi, Yu Chen Barrett, Ronald Bowsher, et.al.
Review: Recommendations for the validation of immunoassays used for detection of host antibodies against biotechnology products
J of Pharm Biomed Anal, 48(5), 1267-1281 (2008)
Metabolites In Safety Testing (MIST)
Dennis A. Smith and R. Scott Obach
Seeing Through the MIST: Abundance Versus Percentage. Commentary on Metabolites In Safety Testing
Drug Metabolism and Disposition 33(10), 1409-1417 (2005)
Thomas A. Baillie, Mitchell N. Cayen, Hassan Fouda, Ronald J. Gerson, James D. Green, et.al.
Drug Metabolites in Safety Testing
Toxicology and Applied Pharmacology 182(3), 188-196 (2002)
Regulated Bioanalysis
Natasha Savoie, Brian Booth, Tony Bradly, Fabio Garofolo, Nicola Hughes et.al.
The 2nd Calibration and Validation Group Workshop on recent issues in Good Laboratory Practice bioanalysis
Bioanalysis 1(1), 19-30 (2009)
Natasha Savoie, Fabio Garofolo, Peter van Amsterdam, Brian P Booth, Douglas M Fast et.al.
2009 White Paper on Recent Issues in Regulated Bioanalysis from The 3rd Calibration and Validation Group Workshop
Bioanalysis 2(1), 53-68 (2010)
Richard Abbott
Conference Report: The Broadening Scope of Validation: Towards Best Practices in the World of Bioanalysis
Bioanalysis 2(4), 703-708 (2010)
C.T. Viswanathan
Regulatory observations in bioanalytical determinations
Bioanalysis 2(7), 1325-1329 (2010)
Natasha Savoie, Fabio Garofolo, Peter van Amsterdam, Surendra Bansal, Chris Beaver et.al.
2010 White Paper on Recent Issues in Regulated Bioanalysis & Global Harmonization of Bioanalytical Guidance
Bioanalysis 2(12), 1945-1960 (2010)
Computer Validation
Kevin Martin, Arthur Perez
GAMP 5 Quality Risk Management Approach
Pharmaceutical Engineering, May/June 2008, Vol.28 No. 3
Surendra Bansal, Thomas Layloff, Ernest Bush, Martha Hamilton, Edward Hankinson et.al.
Qualification of Analytical Instruments for Use in the Pharmaceutical Industry: A Scientific Approach
AAPS PharmSciTech 2004;5 (1) Article 22