Date(s) And Time(s):
Apr 7 2011 8:00AM - Apr 7 2011 5:00PM
Hilton Rockville Hotel
1750 Rockville Pike
Rockville, MD 20852
How to Use (Q)SAR to Assess Impurities for Potential Genotoxicity.
Join industry scientists and regulators addressing what constitutes an acceptable in silico evaluation and how to incorporate public and proprietary sources of data into an integrated assessment. The timing of this particular workshop will provide critical input on the discussions for the June 2011 meeting for ICH M7 (Mutagenic Impurities).
• Computational assessment using (Q)SAR to predict the outcome of Ames for potential genotoxic impurities
• Criteria needed to assess the adequacy of databases for confidence in a negative outcome
• Addressing conflicting outputs from (Q)SAR
• Adding weight-of-evidence to (Q)SAR assessments; the role of literature, scientific judgment and proprietary data
• Understanding similarity in chemical space; how experimental evidence of the API can aid the assessment of potential genotoxic impurities
At the conclusion of this meeting, participants should be able to:
• Define the criteria to evaluate the adequacy of a structural alert analysis to have confidence in a negative result from a database
• Summarize the standards needed to judge the appropriateness of a (Q)SAR model
• Explain, gain insight and reach consensus from all regions on the procedure for conducting a (Q)SAR evaluation
• Analyze and determine the acceptability of in-house databases for (Q)SAR modeling
Laboratory and computational scientists from industry and academia involved in drug discovery and development, regulators, regulatory affairs specialists, program managers, chemists and database managers.
Contact Constance Burnett at the DIA office by telephone 215.293.5800, fax 215.442.6199 or email Constance.Burnett@diahome.org.