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AAPS CLINICAL PHARMACOLOGY AND TRANSLATIONAL RESEARCH (CPTR)

Wednesday, November 14

2:00 pm – 4:00 pm

Roundtable
ACPE #073-999-07-546-L04

Classic scaling techniques between species (and between in vitro and in vivo) relies upon inherent “likeness” between each species. Our increasing knowledge of individual systems in different animal species has identified more and more examples where there are significant dissimilarities between species. Rather than defeat scaling approaches this should give us the opportunity to develop advanced models with improved predictive ability. Although the knowledge between the classical toxicological species (rat and dog) and man is becoming well developed there are significant gaps in relation to other economically and socially important species of relevance to veterinary medicine. In essence to ask the question: where are the differences a matter of degree (and maybe predictable through scaling) and where are they discrete (less predictable).

Moderators

Krishan Kumar, Ph.D.
Merial Ltd.

Carol Davis, Ph.D.
Davis Consulting and Training

Understanding Species Metabolism & Toxicity Differences in Terms of Cytochrome P450 Enzymes
Fred P. Guengerich, Ph.D.
Vanderbilt University

Comparative Physiology and Metabolism: Beyond Rodents, Dogs, and Primates
Rob Hunter, Ph.D.
Elanco Animal Health

Interspecies Pharmacokinetic Scaling: Principles, Applications, and Limitations
Iftekhar Mahmood, Ph.D.
U.S. Food and Drug Administration

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