DIA 48th Annual Meeting
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Skin-drug Biotransformation: What Testing Should We Do?
Track : Track 04: Nonclinical and Translational Development/Early Phase Clinical Development
Program Code: 221
Date: Tuesday, June 26, 2012
Time: 10:00 AM to 11:30 AM  EST
 Keith Burkhart, FDA, United States
 J. Steven Leeder, Children's Mercy Hospitals and Clinics, United States
 Keith Burkhart, FDA, United States
 Jessica Whritenour, Pfizer Inc, United States
AERS data mining supports the hypothesis that drugs associated with Stevens Johnson Syndrome (SJS) undergo biotransformation. Reviews of the role of drug metabolism and SJS and preclinical testing for skin hypersensitivity are provided.

Learning Objectives:
Describe AERS data mining findings that support a role for skin biotransformation of drugs associated with Stevens Johnson Syndrome (SJS)
Review the evidence for drug metabolism in SJS
Discuss industry nonclinical testing for skin hypersensitivity and relevance to SJS.