Contains Nonbinding Recommendations
Bioanalytical Method Validation
05/24/18
as recommendations, unless specific regulatory or statutory requirements are cited. The use of
the word should in Agency guidances means that something is suggested or recommended, but
not required.
II. BACKGROUND
The 2001 guidance for industry on Bioanalytical Method Validation was originally based on the
deliberations of two workshops described in publications entitled:
• Analytical Methods Validation: Bioavailability, Bioequivalence, and Pharmacokinetic
Studies
3
• Bioanalytical Methods Validation: A Revisit With a Decade of Progress
4
Additional workshops, summarized in the following publications, have informed subsequent
revisions (e.g., the 2013 draft guidance for industry entitled Bioanalytical Method Validation
5
):
• Quantitative Bioanalytical Methods Validation and Implementation: Best Practices for
Chromatographic and Ligand Binding Assays
6
• The AAPS/FDA Workshop on Incurred Sample Reanalysis
7
• The AAPS Workshop on Crystal City V — Quantitative Bioanalytical Method Validation
and Implementation: 2013 Revised FDA Guidance
8
3
Shah, VP, KK Midha, S Dighe, IJ McGilveray, JP Skelly, A Yacobi, T Layloff, CT Viswanathan, CE Cook, RD
McDowell, KA Pittman, S Spector, 1992, Analytical Methods Validation: Bioavailability, Bioequivalence, and
Pharmacokinetic Studies, Pharm Res, 9:588-592.
4
Shah, VP, KK Midha, JW Findlay, HM Hill, JD Hulse, IJ McGilveray, G McKay, KJ Miller, RN Patnaik, ML
Powell, A Tonelli, CT Vis wanathan, A Yacobi, 2000, Bioanalytical Methods Validation: A Revisit With a Decade
of Progress, Pharm Res, 17:1551-1557.
5
When final, this guidance will represent the FDA’s current thinking on this topic. For the most recent version of a
guidance, check the FDA Drugs guidance Web page at
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm
6
Viswanathan, CT, B Surendra, B Booth, AJ DeStefano, MJ Rose, J Sailstad, VP Shah, JP Skelly, PG Swann, R
Weiner, 2007, Quantitative Bioanalytical Methods Validation and Implementation: Best Practices for
Chromatographic and Ligand Binding Assays, Pharm Res, 24:1962-1973.
7
Fast, DM, M Kelley, CT Viswanathan, J O’Shaughnessy, SP King, A Chaudhary, R Weiner, AJ DeStefano, D
Tang, 2009, Workshop Report and Follow-Up — AAPS Workshop on Current Topics in GLP Bioanalysis: Assay
Reproducibility for Incurred Samples — Implications of Crystal City Recommendations, AAPS J, 11:238-241.
8
Booth, B, ME Arnold, B DeSilva, L Amaravadi, S Dudal, E Fluhler, B Gorovits, SH Haidar, J Kadavil, S Lowes,
R Nicholson, M Rock, M Skelly, L Stevenson, S Subramaniam, R Weiner, E Woolf, 2015, Workshop Report: