Method Validation Guidelines - - BioPharm International

ADVERTISEMENT

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.


blog comments powered by Disqus

ADVERTISEMENT

ADVERTISEMENT

EMA Warns of Falsified Herceptin Vials
April 16, 2014
Mallinckrodt to Acquire Questcor Pharmaceuticals
April 16, 2014
American CryoStem and Rutgers University File Joint Patent on Stem Cell Platform
April 11, 2014
Center for Biologics Evaluation and Research Relocates
April 11, 2014
PhRMA Report Reveals Growth Trajectories and Policy Factors Affecting Biopharmaceutical Growth
April 11, 2014
Author Guidelines
Source: BioPharm International,
Click here