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Dissolution Method Development for Immediate release Solid Oral Dosage Forms Quick Start Guidelines for Early Phase Development Compounds . David Fortunato email: Johnson and Johnson Pharmaceutical Research and Development Spring House, PA. Introduction tion and analytical Method Development processes. I. n the Pharmaceutical Industry,as product devel- For example,does the label claim for the proposed opment continues to multiply at increasingly dosage strengths reflect free base or salt formula- faster rates, Dissolution Method Development tions? Quickest results are obtained when the Early must be able to keep pace with the increased Phase Development Teams are able to supply the number of products that are entering the pipeline. Dissolution Scientist with excipients,placebo granu- For many of these products,initial Dissolution lations and capsule shells.
12 Dissolution Technologies | AUGUST 2005 Dissolution Method Development for Immediate Release Solid Oral Dosage Forms “Quick Start Guidelines for Early Phase Development Compounds”
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