Thomas O’Connor

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Thomas O’Connor is chemical engineer, science staff at the Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, FDA.

Articles

Regulatory Considerations for Controlled Correspondence Related to Generic Drug Chemistry

Regulatory Considerations for Controlled Correspondence Related to Generic Drug Chemistry

Geoffrey Wu;Lane Christensen;Thomas O’Connor;Frank Holcombe Jr.;Susan Rosencrance;Andre Raw;Kristina Adams;Xiaochuan Yang;Min Li
September 1st 2015

An analysis of controlled correspondence between generic-drug manufacturers and FDA reveals patterns in questions about specific drug chemistry topics and the response to information provided in FDA guidance documents.

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Flowsheet Models Modernize Pharmaceutical Manufacturing Design and Risk Assessment

Fernando Muzzio, PhD;Marianthi Ierapetritou;Ravendra Singh;Rohit Ramachandran;M. Sebastian Escotet-Espinoza;Sharmista Chatterjee;Thomas O’Connor;Sau Lee;Maitraye Sen
April 2nd 2015

In-silico design facilitates process optimization and evaluation of process control strategies.

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