Journal
TOXICOLOGY AND APPLIED PHARMACOLOGY
Volume 273, Issue 2, Pages 229-241Publisher
ACADEMIC PRESS INC ELSEVIER SCIENCE
DOI: 10.1016/j.taap.2013.04.039
Keywords
Safety pharmacology; International Conference on Harmonisation; Cardiovascular; Central nervous system; Respiratory; Risk
Categories
Funding
- Innovative Medicines Initiative (IMI) SafeSciMET training programme
- Epilepsy Research UK [P1105] Funding Source: researchfish
- Medical Research Council [G0700654] Funding Source: researchfish
- MRC [G0700654] Funding Source: UKRI
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Safety pharmacology (SP) is an essential part of the drug development process that aims to identify and predict adverse effects prior to clinical trials. SP studies are described in the International Conference on Harmonisation (ICH) S7A and S7B guidelines. The core battery and supplemental SP studies evaluate effects of a new chemical entity (NCE) at both anticipated therapeutic and supra-therapeutic exposures on major organ systems, including cardiovascular, central nervous, respiratory, renal and gastrointestinal. This review outlines the current practices and emerging concepts in SP studies including frontloading, parallel assessment of core battery studies, use of non-standard species, biomarkers, and combining toxicology and SP assessments. Integration of the newer approaches to routine SP studies may significantly enhance the scope of SP by refining and providing mechanistic insight to potential adverse effects associated with test compounds. (C) 2013 Elsevier Inc. All rights reserved.
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