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© 2023 MJH Life Sciences and Pharmaceutical Technology. All rights reserved.
© 2023 MJH Life Sciences™ and Pharmaceutical Technology. All rights reserved.
Thomas O’Connor is chemical engineer, science staff at the Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, FDA.
September 01, 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.
April 02, 2015
In-silico design facilitates process optimization and evaluation of process control strategies.