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CDER has released a draft guidance providing its current thinking on the critical quality attributes (CQAs) that should be assessed during the development of chewable tablets. The guidance has applicability to NDAs, ANDAs, CMC supplements and INDs. Recommendations are provided on evaluating hardness, disintegration, and dissolution. Also addressed are labeling and nomenclature considerations. Included is an index on mathematical models for measuring tablet hardness.
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INTERNATIONAL PHARMACEUTICAL QUALITY
Inside the Global Regulatory Dialogue
