Method validation essentials, limit of blank, limit of detection, and limit of quantitation: Care needs to be made to match the method of limit determination to the analytical method

BioPharm International

Volumn 28, Issue 4, 2015, Pages 48-51

  Little, Thomas A ^a  

^a Thomas A Little Consulting   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; LIMIT OF BLANK; LIMIT OF DETECTION; LIMIT OF QUANTITATION; PARAMETERS; SAMPLE SIZE; SIGNAL NOISE RATIO; VALIDATION PROCESS;

EID: 84940863159     PISSN: 1542166X     EISSN: 19391862     Source Type: Trade Journal    
DOI: None     Document Type: Article

References (3)

1. ICH Q2, Validation of Analytical Procedures: Test and Methodology, November 2005.
2. NIST, Engineering Handbook, www.itl.nist.gov/div898/handbook/mpc/section4/mpc46.htm
3. Thomas A. Little Consulting, Method Validation Quick Reference Guide, Version 5, http://qualitybydesignconsulting.com/tools/index.php, accessed Mar. 19, 2015.