3 - 4 May 2018
2018 Genetic Toxicology Association (GTA) Meeting
The Genetic Toxicology Association held its Annual Meeting on the 3rd and 4th of May, 2018. The Meeting took place at the John M. Clayton Hall Conference Center, University of Delaware.
Lhasa attended this event and organised a workshop prior to the conference.
All presentation slides, as well as delegate information and a summary of the poll results can be found below.
Deriving compound specific exposure limits for chemicals used in pharmaceutical synthesis
The calculation of compound specific Acceptable Intakes (AIs)/Permissible Daily Exposures (PDEs) to establish allowable limits for impurities in pharmaceuticals is an accepted practice. However, the process is often time consuming and costly, with the potential for duplicative and/or non-equivalent assessments being generated at multiple companies and submitted to regulatory agencies. Led by Lhasa Limited, the AI/PDE project has brought together an expert, cross-industry consortium to share and harmonise AI and PDE monographs for reagents and solvents commonly used in pharmaceutical synthesis.
Deriving compound specific exposure limits for chemicals used in pharmaceutical synthesis (Krista Dobo, Pfizer Worldwide Research and Development)
AI and PDE data sharing project for Pharmaceutical Impurities (Will Drewe, Lhasa Limited)
Data selection case study (Zhanna Sobol, Pfizer Worldwide Research and Development)
Adjustment Factors (Joel Bercu, Gilead)
Permissible exposures without data (John Nicolette, Abbvie)
Approaches for establishing limits for different routes of administration (Trish Parris, Astra Zeneca)
Rich Williams, Chief Scientific Officer, also presented the following: Are all Ames Strains in the OECD Mutagenicity Test Guideline 471 useful and necessary? An analysis of large mutagenicity data sets for the IWGT
Headline Event (shown first above featured)
- Deriving Compound Specific Exposure Limits for Chemicals Used in Pharmaceutical Synthesis
- Adjustment Factors
- AI and PDE Data Sharing Projects for Pharmaceutical Impurities
- Data Selection for Calculating the Acceptable Intake of Ethylene Oxide (CAS# 75-21-8)
- Permissable Exposures Without Data
- Approaches for Establishing Limits for Different Routes of Administration
- Are all Ames Strains in the OECD Mutagenicity Test Guideline 471 useful and necessary? An analysis of large mutagenicity data sets for the IWGT