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

Despite AbbVie Snub, Shire Says it Will Double Sales by 2020
October 24, 2014
Novartis Reports Positive Results for Secukinumab in Ankylosing Spondylitis Trials
October 23, 2014
Pall ForteBio Releases Bioprocessing Contamination Detection Kit
October 22, 2014
FDA Panel Unanimously Backs Secukinumab for the Treatment of Psoriasis
October 22, 2014
Roche to Expand and Improve its Basel Site
October 22, 2014
Author Guidelines
Source: BioPharm International,
Click here