How to Maintain Suitable Analytical Test Methods: Tools for Ensuring a Validation Continuum - - BioPharm International

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How to Maintain Suitable Analytical Test Methods: Tools for Ensuring a Validation Continuum


BioPharm International


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.


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