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What Impact should ICH Q8 have on ICH Q6A Decision Trees?

What Impact should ICH Q8 have on ICH Q6A Decision Trees?. Ajaz S. Hussain, Ph.D. Deputy Director, OPS/CDER/FDA. Outline. An overview of ICH Q6A dissolution decision trees Relationship between disintegration and dissolution test? Mechanistic basis? Causal link?

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Ir tablet pharm res - PowerPoint PPT Presentation

What Impact should ICH Q8 have on ICH Q6A Decision Trees?