Method Validation Guidelines - - BioPharm International

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Method Validation Guidelines


BioPharm International


9. Guidance for Industry: Bioanalytical Method Validation. US Food and Drug Administration web site. Available at: http:// http://www.fda.gov/cder/guidance/4252fnl.htm.

10. ICH Q9: Quality Risk Management. Draft Consensus Guideline. US Food and Drug Administration web site. Available at: http:// http://www.fda.gov/cber/gdlns/ichq9risk.htm.

11. ICH Q6A: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances. Guidance for Industry. US Food and Drug Administration web site. Available at: http:// http://www.fda.gov/cder/guidance/guidlist.pdf.

12. ICH Q6B Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products. Guidance for Industry. US Food and Drug Administration web site. Available at: http:// http://www.fda.gov/cder/guidance/Q6Bfnl.PDF.

13. Kleinbaum DG, Kupper LL, Muller KE. Applied Regression Analysis and Other Multivariable Methods. 2nd ed. Boston: PWS-Kent Pub Co; 1988.


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