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Scale-down Model Qualification anddown Model …
Scale-down Model Qualification andScaledown Model Qualification and Use in Process CharacterizationNathan McKnightCMC Strategy Forum28 January, 2013 Slide 2 Outline Introduction and context Scale-down Model design and key elements Uses and data interpretation Qualification Mitigating uncertainties from Scale-down Model useMitigating uncertainties from scaledown Model use Summary and conclusionsSlide 3 Introduction Small-scale models can be developed and used to support process development studies. The development of a Model should account for scale effects and be representative of the proposed commercial process. Aeffects and be representative of the proposed commercial process. A scientifically justified Model can enable a prediction of quality, and can be used to support the extrapolation of operating conditions across multiple scales and equipment. ICH Q11 Step 4 It is important to understand the degree to which models represent the commercial process, including any differences that might exist, as this maycommercial process, including any differences that might exist, as this may have an impact on the relevance of information derived from the models.
Outline Slide 2 • Introduction and context • Scale-down model design and key elements • Uses and data interpretation • Qualification • Mitigating uncertainties from scaleMitigating uncertainties from scale-down model usedown model use
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