SPS CE PM3—Gastrointestinal Safety Pharmacology: From Preclinical to Clinical

The Continuing Education (CE) courses provide excellent lectures to participants at Annual Meetings. The SPS PM 3 Continuing Education Course, chaired by Scott Mittelstadt, PhD, Abbott Laboratories and Mark A. Osinski, PhD, Covance Laboratories Inc. is a featured course for 2012. Gastrointestinal (GI) responses to drugs, such as diarrhea, constipation and emesis, are some of the most frequently reported adverse effects in the clinical development of new chemical entities. Despite the frequency of these effects, they are not considered life threatening and preclinical assessment of the GI system is not required by regulatory agencies prior to first in human studies. Therefore, pharmaceutical scientists need to assess the importance and the type of preclinical GI assays to be conducted within their own companies. This course will focus on the basic physiology of gastric emptying, intestinal transit, absorption/secretion, and emesis. We will also discuss advantages and disadvantages of different preclinical GI models. Finally, the course will discuss potential strategies that companies can implement to reduce the risk for unexpected clinical effects on the gastrointestinal system.

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