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3. ICH Harmonized Tripartite Guideline prepared within the International Conference on the Harmonization of Technical Requirements for the Registration of Pharmaceuticals for Human Use (ICH) Q2A, Text on Validation of Analytical Procedures, 1994. Available from http://www.ich.org/ich5q.html.
4. ICH Harmonized Tripartite Guideline prepared within the International Conference on the Harmonization of Technical Requirements for the Registration of Pharmaceuticals for Human Use (ICH) Q2B, Validation of Analytical Procedures: Methodology, 1996. Available from http://www.ich.org/ich5q.html.
5. Council of Europe, European Department for the Quality of Medicines, Technical Guide for the Elaboration of Monographs, 2nd ed., Pharmeuropa, 1996, pp. 1–42 (special issue).