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Transfer of analytical procedures: a panel of strategies selected for risk management, with emphasis on an integrated equivalence-based comparative testing approach |
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| Authors: | Agut C Caron A Giordano C Hoffman D Ségalini A |
| Affiliation: | a Biostatistics, Research & CMC, Sanofi-aventis, 195 Route d’Espagne, 31036 Toulouse, France b Lead Generation to Candidate Realization, Candidate Realization Strategy & Scientific Affairs, Sanofi-aventis, Montpellier, France c Lead Generation to Candidate Realization, Analytical Sciences, Sanofi-aventis, Montpellier, France d Biostatistics, Research & CMC, Bridgewater, USA |
| Abstract: | |
| Keywords: | ANOVA, analysis of variance API, Active Principal Ingredient CI, confidence interval CQA, critical quality attribute CV, coefficient of variation (referred also as relative standard deviation) DP, drug product GMP, good manufacturing practices LoD, Limit of Detection LoQ, Limit of Quantification IEC, insufficient evidence to conclude NCE, new chemical entity OUCB, one-sided upper confidence bound QC, quality control |
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