Submitting Advanced Bioanalytical Test Methods for Regulatory Approval - - BioPharm International

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Submitting Advanced Bioanalytical Test Methods for Regulatory Approval


BioPharm International


References:

1. Krause, SO. Qualifying Release Laboratories in Europe and the United States. BioPharm International 2004; 17 (3):28-36.

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

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

4. Krause, SO. Analytical Method Validation for Biopharmaceuticals, BioPharm International, A Guide to Validation 2005; 24-32.

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

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


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