Michael J. Kukulka
Michael J. Kukulka is senior manager, Global Labeling, Regulatory Affairs, PRA Health Sciences (Deerfield, IL)
Articles
Evaluation of Physical Characteristics of Dexlansoprazole Orally Disintegrating Tablets
August 2nd 2018This article describes the approaches used during the development of a dexlansoprazole delayed-release orally disintegrating tablet (ODT) to evaluate tablet size and texture as they relate to disintegration rate and patient experience; in addition, the resistance to alcohol was also characterized.
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Published: October 11th 2024 | Updated: October 18th 2024
Buy, Sell, Hold: Cell and Gene Therapy - Part 1
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CPHI Milan Announces 2024 CPHI Pharma Award Finalists
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Discovery to Commercialization: The Right Partnerships are Key to Streamlined Drug Development
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Automate Aseptic Filling: Closing the System at Full Modularity
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Untethered Data: Unifying and Contextualizing Drug Discovery Data
Published: November 8th 2024 | Updated: November 23rd 2024
Application of Validation Principles to the Training Quality System: Part 9, Quality Risk Management Hazard Identification
