FDA-CDER and HESI | Nitrosamine Ames Data Review and Method Development Workshop

Events / Workshops / Webinars
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Date:
October 15 - 16, 2024
Day1:
Tue, Oct 15 8:00 AM - 5:00 PM ET
Day2:
Wed, Oct 16 8:00 AM - 4:00 PM ET

Location:

FDA White Oak Campus, Room 2031, Building 2. 10903 New Hampshire Avenue, Silver Spring.

Goals and Objectives:

  • To provide a forum for open discussion between regulators and industry on the data generated using enhanced Ames assay methodologies to assess the mutagenic potential of nitrosamines.
  • Present and hold open discussions on specific questions related to the generated data.
  • Discuss recommendations on the relevant and most predictive test conditions of the Ames test for more reliable prediction of the mutagenic potential of nitrosamines.
  • Discuss the correlation of Ames assay results for nitrosamine drug substance related impurities (NDSRIs) and in vivo carcinogenicity/mutagenicity.
  • Generate recommendations for publication in a scientific journal and make them publicly available.

https://www.fda.gov/drugs/fda-cder-and-hesi-nitrosamine-ames-data-review-and-method-development-workshop-10152024

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Is it possible to have virtual audience for its maximum reach.

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Nitrosamine Ames Data Review and Method Development: proceedings of a US FDA/HESI workshop
https://academic.oup.com/mutage/advance-article/doi/10.1093/mutage/geag011/8483857

Abstract

Detection of *N-*nitrosamines (NA) in pharmaceuticals became a point of interest due to the mutagenic and carcinogenic potential of some compounds of this class, and their identification as nitrosated forms of marketed drugs, otherwise known as NA Drug Substance-Related Impurities (NDSRIs). The Ames test is used to assess the mutagenic potential of drug impurities, including NAs. Concerns over the sensitivity of the Ames test, as recommended in Organization for Economic Co-operation and Development Test Guideline 471, in predicting the rodent carcinogenic potential of NAs has prompted optimization of several test parameters used for detecting the mutagenicity of NAs (e.g. methods used for metabolic activation and the selection of tester strains). In order to discuss optimal Ames test conditions for the evaluation of NAs, including NDSRIs, the Office of New Drugs in the US Food and Drug Administration’s Center for Drug Evaluation and Research and the Health and Environmental Sciences Institute’s Genetic Toxicology Technical Committee co-organized and co-sponsored a workshop entitled “Nitrosamines: Ames Data Review and Method Development Workshop”. The workshop featured five sessions addressing charge questions pertinent to the Ames test conditions and performance through the presentation of data and panel discussions. This report outlines the key takeaway points from the workshop.

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