DIA/FDA Quantitative Structure-activity Relationship (Q)SAR Approaches to Assessing Genotoxic Impuri

Venue: Hilton Rockville Hotel

Location: Rockville, Maryland, United States

Event Date/Time: Apr 07, 2011
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Description

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).

FEATURED TOPICS
• 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




Event Code:
11015

Venue

maria.keller@diahome.org
Rockville
Maryland
United States
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