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Tripartite Standard
Found 2 free book(s)
ICH HARMONISED TRIPARTITE GUIDELINE
database.ich.orgICH Harmonised Tripartite Guideline Having reached Step 4 of the ICH Process at the ICH Steering Committee meeting ... Where no such reference standard exists, a characterized in-house reference material should be established and …
VALIDATION OF ANALYTICAL P TEXT AND METHODOLOGY …
database.ich.orginclude but is not limited to: the sample, the reference standard and the reagents preparations, use of the apparatus, generation of the calibration curve, use of the formulae for the calculation, etc. 2. SPECIFICITY Specificity is the ability to assess unequivocally the analyte in the presence of components which may be expected to be present.