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Toxicity Testing and Qualification of Impurities, How Far is Too Far?
Wednesday, November 14
9:00 am – 11:00 am
Roundtable
ACPE #073-999-07-554-L04
ICH and FDA guidance mandate qualification of impurities and degradants with a structural alert for geneotic and carcinogenicity potential. In recent times there is an increased number of requests for impurity/degradent qualification. Often times the basis for these requests are based on EPA findings citing the structure is similar to anilin or dextran. These tests are time consuming and decisions are made on the basis of weight of evidence. This discussion will try to gain an understanding and educate sponsor companies on the need for toxicity testing or structural qualification so that companies understand the rationale and proactively qualify the impurities and degradents.
Moderator
Prasad N.V. Tata, Ph.D., F.C.P.
Mallinckrodt, Inc.
What Constitutes Reasonable Structural Alert? Is EPA Good for Pharmaceuticals?
Prakash T. Diwan, Ph.D.
Indian Institute of Chemical Technology
What Constitutes Structural Alert is QSAR Can Be Substituted for Lab Work?
Lawrence Yu, Ph.D.
U.S. Food and Drug Administration
Do We Have to Revisit ICH Guidance on Genetox and Carcinogenicity Studies?
David Jacobson-Kram, D.A.B.T.
U.S. Food and Drug Administration