Method validation guidelines

BioPharm International

Volumn 18, Issue 9 SUPPL., 2005, Pages 28-33

  Kanarek, Alex D ^a  

^a Bio Development Consulting   (Canada)

Author keywords

[No Author keywords available]

Indexed keywords

ACCURACY; ANALYTIC METHOD; CLINICAL STUDY; DOCUMENTATION; DRUG APPROVAL; DRUG INDUSTRY; DRUG INFORMATION; FOOD AND DRUG ADMINISTRATION; GOOD LABORATORY PRACTICE; GOOD MANUFACTURING PRACTICE; LICENCE; LICENSING; PRACTICE GUIDELINE; QUALITY CONTROL; REPRODUCIBILITY; REVIEW; VALIDATION PROCESS;

EID: 26944435918     PISSN: 1542166X     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (2)

1. Title 21 -Food and Drugs; Subchapter C - Drugs: General Part 211. Current Good Manufacturing Process for Finished Pharmaceuticals; Subpart I: Laboratory Controls. US Food and Drug Administration web site. Available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart= 211&showFR=1.
2. Kleinbaum DG, LL Kupper, Muller KE. Applied Regression Analysis and Other Multivariable Methods. 2nd ed. Boston: PWS-Kent Pub Co; 1988.