The Impact of Drug-Induced Effects on the Gastrointestinal System
- Resource Type
- Authors
- Susan M.G. Goody; Renaud Fleurance; Marie-Luce Rosseels
- Source
- Subject
- Drug
medicine.medical_specialty
business.industry
media_common.quotation_subject
Safety pharmacology
Gastrointestinal system
Safety profile
Quality of life (healthcare)
Drug development
medicine
Intensive care medicine
business
Adverse effect
Organ system
media_common
- Language
Gastrointestinal (GI) adverse events are one of the most common adverse drug reactions in humans, often affecting patient quality of life and compliance and having the potential to impede drug development. Although the GI system is not listed as one of the core safety pharmacology organ systems in the S7A International Conference on Harmonization guidelines, the effect(s) of new pharmaceuticals on the GI system should still be characterized. This chapter begins by providing an overview of some assays that can be used to screen and rank order compounds to enable selection of a lead molecule with a favorable GI profile. It then explains how nonclinical observations of drug-induced emesis (vomiting) and diarrhea can interfere with characterizing the safety profile of other organ systems. Potential mitigation strategies for managing GI issues and a high-level overview of future directions of the field for safety pharmacologists will be discussed.