EBF
EBF
EBF
European
Bioanalysis
Forum


EBF vzw is the registered non-profit organisation of the European Bioanalysis Forum

Listing of and reference to various publications and conference papers judged relevant for the conduct of regulated bioanalysis. Regulatory documents are listed on: Publications / Regulatory Documents. Publications by the EBF are presented on: Publications / EBF Publications

Bioanalytical Method Validation (BMV)

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, Vol 11, No. 2, Jun 2009, 238-241

Workshop Report and Follow-Up-AAPS Workshop on Current Topics in GLP Bioanalysis: Assay Reproducibility for Incurred Samples-Implications of Crystal City Recommendations
Closing Remarks Summary, February 2008

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, Vol 9, No. 1, 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; Vol. 24 No. 10, Oct 2007

Vinod P. Shah
The History of Bioanalytical Method Validation and Regulation: Evolution of a Guidance Document on Bioanalytical Methods Validation The AAPS Journal 2007; 9 (1) Article 5

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.
Pharm Res. 2000;17:1551-1557

Vinod P. Shah, Kamal K. Midha, Shrikant Dighe, Iain J. McGilveray, Jerome P. Skelly, et.al.
Analytical methods validation: bioavailability, bioequivalence and pharmacokinetic studies.
Pharm Res. 1992;9:588-592

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 Vol. 23, No. 2, Feb 2006, 312-328

BMV Macromolecules

Marian Kelly and Binodh DeSilva
Key elements of bioanalytical method validation for macromolecules
The AAPS Journal; Vol. 9, No. 2, Jun 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; Vol. 22, No. 9, Sep 2005
DeSilva B, Smith W, Weiner R, Kelley M, Smolec J, et.al.
Recommendations for the Bioanalytical Method Validation of Ligand-Binding Assays to Support Pharmacokinetic Assessments of Macromolecules
Pharmaceutical Research; Vol. 20, No. 11, Nov 2003

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, Vol. 18, No. 9, September 2001

Findlay JW, Smith WC, Lee JW, Nordblom GD, Das I, et.al.
Validation of immunoassays for bioanalysis: a pharmaceutical industry perspective.
J Pharm Biomed Anal. Vol. 21, No. 6, Jan 2000, 1249-73.

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, Vol. 48, No. 5, Dec 2008, 1267-1281

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, 2005: Vol. 33, No. 10, 1409-1417

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, Vol 182, No. 3, Aug 2002, 188-196