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© 2021 MJH Life Sciences and Pharmaceutical Technology. All rights reserved.
© 2021 MJH Life Sciences™ and Pharmaceutical Technology. All rights reserved.
Lachman Consultant Services, Inc.
Aloka Srinivasan, PhD is vice-president, Regulatory Services, Lachman Consultant Services, Inc.
October 02, 2019
The author provides a direction for identifying genotoxic impurities early in the drug development process, regulating genotoxic impurities at acceptable levels in the API or drug product, and avoiding negative product regulation late in the development and/or marketing process, including expensive recalls.
April 15, 2014
The selection of excipients is important in generic formulations due to the impact it has on the risk and performance of generic drugs.