REFERENCES:
1. International Conference on Harmonisation; Guideline on Validation of Analytical Procedures (Q2A). 60 Federal Register
11259-11262 (1995).
2. International Conference on Harmonisation; Guideline on Validation of Analytical Procedures: Methodology (Q2B). Federal
Register 27463-27467 (1997).
3. Krause SO. Qualifying Release Laboratories in Europe and the United States. BioPharm International. 2004; 17 (3):28-36.
4. Krause SO. Development and validation of analytical methods for biopharmaceuticals, part I: development and optimization.
BioPharm International. 2004; 17(10):52-61.
5. Krause SO. Development and validation of analytical methods for biopharmaceuticals, part II: formal validation. BioPharm International. 2004; 17(11):46-52.
6. Krause SO. Analytical Method Validation for Biopharmaceuticals, BioPharm International Guide to Validation. 2005; 24-32.
7. Krause SO. Submitting Advanced Bioanalytical Test Methods for Regulatory Approval. BioPharm International Guide to Bioanalytical Advances. 2005; 21-27.
8. United States Pharmacopoeia (USP). General Chapter in Draft, <1226> Verification of Compendial Procedures, Pharmacopeial
Forum, 2005.
9. Fuege J. The Validation Continuum: An FDA Perspective, Presented by Mary Malarkey, Journal of Validation Technology. 2005; 11(3):253-6.
10. Krause SO. Analytical Method Validation for Biopharmaceuticals. Invited General Session Presentation, IBC International
Conference: Quality Systems and Regulatory Compliance, Reston, VA, April 05, 2005.
|
