Nitrosamines arise via nitrosating agents (nitrites, NO2/NOx, nitrous acids/oxides) reacting with secondary/tertiary amines or some amides, yielding high-risk N-nitroso compounds. Regulatory actions ...
This article discusses the role and importance of excipients in medicines, focusing on regulatory aspects crucial for pharmaceutical companies. The aim of the article is to provide an overview of ...
In part 1 of a multi-part series, David Schoneker, president, Black Diamond Regulatory Consulting, explains the difference between a new excipient and a novel excipient and what goes into developing a ...
NEW YORK, Oct. 14, 2024 /PRNewswire/ -- IFF (NYSE:IFF) Pharma Solutions will demonstrate the critical role of excipients in drug formulation by showcasing breakthrough research at AAPS 2024 PharmSci ...
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