Regulatory Considerations for Alcohol-Induced Dose Dumping of Oral Modified-Release Formulations

This article looks at the current status of alcohol-induced dose dumping of modified-release formulations and the need for regulatory harmonization in handling this challenge.

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By Thomas P. Friebe, Firouz Asgarzadeh, Ann Gray, Kevin Hughes, Johann-Philipp Hebestreit, Yvonne Rosiaux, Mahmud Yunis, Amina Faham
Pharmaceutical Technology
Volume 38, Issue 10, pg 40-46
Regulatory Considerations for Alcohol-In
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