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Reflection paper on the dissolution specification for
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Reflection paper on the dissolution specification …
www.ema.europa.euReflection paper on the dissolution specification for generic solid oral immediate release products with systemic action EMA/CHMP/CVMP/QWP/336031/2017 Page 2/10
Reflection paper on the dissolution specification …
www.ema.europa.euperformance. 97 However, in all cases the dissolution profiles at increased stirring speeds should have sufficient 98 discriminatory power for drug product quality control .