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2. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use ICH Guideline Q2(R1): Validation of analytical procedures: text and methodology. Geneva, Switzerland www.ich.org/LOB/media/
3. What is test method qualification? Proceedings of the WCBP CMC strategy forum, 24 July 2003;Ritter;BioProcess Int.,2004
4. Kanarek AD Method validation guidelines http://biopharminternational.findpharma.com/