Dr. George Johnson, Swansea University - Qepler Summits And Conferences

Dr. George Johnson

Associate Professor in the Institute of Life Science
Swansea University
United Kingdom
Founded in 1920, Swansea University is a research-led institution with an excellent reputation for the quality of its student experience.

Dr. George Johnson is an Associate Professor in the Institute of Life Science at Swansea University, UK. George is co-chair of the Quantitative Workgroup within the Health and Environmental Science Institute (HESI) Genetic Toxicology Technical Committee (GTTC).

Dr. Johnson carries out research and consultancy in the area of quantitative analysis of genetic toxicity and cancer bioassay data, for application in human health risk assessment.

Related Sessions:

2nd Annual Genotoxic Impurities in
Pharmaceuticals Summit 2021

Genotoxic Impurities in Pharmaceuticals strategies & new methodologies: analysis, in silico & regulations.
  • 15 Jul 2021
  • Virtual,
  • Pharma
Day 1: Thursday, 15 July 2021
CASE STUDY: Quantitative Analysis of In Vivo Mutagenicity Dose-Response Data for Risk Assessment and Regulatory Decision-making: A Case Study of Alkylnitrosamines.
  • Use of genetic toxicity data for assessing alkylnitrosamines
  • Mechanism of action, and dose response characterisation for noteworthy alkylnitrosamines
  • Risk assessment opportunities for specific alkylnitrosamines using these approaches
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3rd Annual Genotoxic Impurities
in Pharmaceuticals Summit 2023

Genotoxic Impurities in Pharmaceuticals strategies & new methodologies: analysis, in silico & regulations.
  • 09 Mar 2023
  • Virtual,
  • Pharma
Day 1: Thursday, 09 March 2023
CASE STUDY: Quantitative analysis of in vivo mutagenicity dose-response data for risk assessment and regulatory decision-making: a case study of alkylnitrosamines
  • Nitrosamine impurities are detectable in some pharmaceutical products.
  • Risk assessment of nitrosamine impurities can be carried out using genetic toxicology data.
  • Benchmark dose metrics can be calculated from in vivo gene mutation data which are used to calculate permitted daily exposures (PDE).
  • A threshold mechanism’ must be defined before the PDE can be used.
  • Adjustment/uncertainty factors used in the PDE may differ when using genetic toxicity data compared to when using cancer bioassay data.
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