Author name: emma.scrafton

Building on the success of our recent webinar, How to establish acceptable intake (AI) limits for Nitrosamine Drug Substance-Related Impurities (NDSRIs), we’re thrilled to present a follow-up that brings you closer to the insightful discussions that unfolded during the interactive Q&A session. In this blog, we’ve gathered questions posed during the webinar and curated written

In our earlier instalments of the Lhasa blog, we have discussed the latest regulatory insights presented by the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and Health Canada regarding acceptable intake limits for Nitrosamine Drug Substance-Related Impurities (NDSRIs). Now, our focus zeroes in on the Enhanced Ames Test (EAT) and its

The U.S. Food and Drug Administration (FDA) recently took a significant step forward in safeguarding public health by issuing a new guidance titled “Recommended Acceptable Intake Limits for Nitrosamine Drug Substance Related Impurities (NDSRIs) Guidance for Industry.” This important update addresses concerns related to NDSRIs, a group of nitrosamine impurities found in numerous drug products,