Listing of relevant White Papers and conference reports on Bioanalytical Method Validation and related fields.

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