Analytical Method Validation for Biopharmaceuticals: A Practical Guide - - BioPharm International

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Analytical Method Validation for Biopharmaceuticals: A Practical Guide


BioPharm International


References 1. FDA. 21 CFR 211, Sections 165(e) and 194(a)(2). Available at: http://www.fda.gov/.

2. PDA. Evaluation, validation and implementation of new microbiological testing methods: PDA Technical Report No. 33. PDA Journal of Pharmaceutical Science and Technology 2000; 54(Suppl. TR33).

3. ICH. Validation of Analytical Procedures. Q2A. Federal Register 1995; 60.

4. ICH. Validation of Analytical Procedures: methodology. Q2B. Federal Register 1996; 62.

5. United States Pharmacopoeia. USP 28 <1225>. Validation of Compendial Methods.

6. Krause SO. Development and validation of analytical methods for biopharmaceuticals, part I: development and optimization. BioPharm International 2004; 17(10):52-61.

7. Krause SO. Development and validation of analytical methods for biopharmaceuticals, part II: formal validation. BioPharm International 2004; 17(11):46-52.

8. CDER. Guidance for Industry. Bioanalytical Method Validation. Bethesda MD: FDA; 2001.

9. CBER. Draft Guidance for Industry. Analytical Procedures and Methods Validation. Bethesda MD: FDA; 2000.

10. Ritter N., et al. What is test method qualification? Proceedings of the WCBP CMC strategy forum, 24 July 2003. BioProcess International 2004; 2(8):32-47.

11. Krause SO. Good analytical method validation practice, part I: setting-up for compliance and efficiency. Journal of Validation Technology 2002; (9):23-32.

12. Krause SO. Good analytical method validation practice, part II: deriving acceptance criteria for the AMV protocol. Journal of Validation Technology 2003; (9):162-78.

13. Krause SO. Good analytical method validation practice, part III: data analysis and the AMV report. Journal of Validation Technology 2003; (10):21-36.

14. Krause SO. Analytical method validation. Presented at IVT's 10th Annual Meeting; 2004 Feb 25-28; Philadelphia, PA.

Stephan O. Krause, Ph.D., validation manager of QC assay support, Bayer HealthCare LLC, 800 Dwight Way, Berkeley, CA, 94701-1986, 510.705.4191,


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