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McGraw-Hill, New York Fernandes JO, Soares C (2007) J Chromatogr A 1175:16 Pittet A, Perisset A, Oberson JM (2004) J Chromatogr A 1035:123130 ICH (2005) Validation of analytical procedures: text and methodology Q2(R1): ICH harmonised tripartite guideline

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