| Title |
Safety pharmacology — Current and emerging concepts
|
|---|---|
| Published in |
Toxicology & Applied Pharmacology, June 2013
|
| DOI | 10.1016/j.taap.2013.04.039 |
| Pubmed ID | |
| Authors |
Junnat Hamdam, Swaminathan Sethu, Trevor Smith, Ana Alfirevic, Mohammad Alhaidari, Jeffrey Atkinson, Mimieveshiofuo Ayala, Helen Box, Michael Cross, Annie Delaunois, Ailsa Dermody, Karthik Govindappa, Jean-Michel Guillon, Rosalind Jenkins, Gerry Kenna, Björn Lemmer, Ken Meecham, Adedamola Olayanju, Sabine Pestel, Andreas Rothfuss, James Sidaway, Rowena Sison-Young, Emma Smith, Richard Stebbings, Yulia Tingle, Jean-Pierre Valentin, Awel Williams, Dominic Williams, Kevin Park, Christopher Goldring |
| Abstract |
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. |
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X Demographics
Geographical breakdown
| Country | Count | As % |
|---|---|---|
| Unknown | 1 | 100% |
Demographic breakdown
| Type | Count | As % |
|---|---|---|
| Members of the public | 1 | 100% |
Mendeley demographics
Geographical breakdown
| Country | Count | As % |
|---|---|---|
| United Kingdom | 2 | 1% |
| South Africa | 1 | <1% |
| Mexico | 1 | <1% |
| Unknown | 142 | 97% |
Demographic breakdown
| Readers by professional status | Count | As % |
|---|---|---|
| Researcher | 24 | 16% |
| Student > Bachelor | 20 | 14% |
| Student > Ph. D. Student | 19 | 13% |
| Student > Master | 16 | 11% |
| Other | 13 | 9% |
| Other | 18 | 12% |
| Unknown | 36 | 25% |
| Readers by discipline | Count | As % |
|---|---|---|
| Pharmacology, Toxicology and Pharmaceutical Science | 26 | 18% |
| Medicine and Dentistry | 26 | 18% |
| Agricultural and Biological Sciences | 17 | 12% |
| Biochemistry, Genetics and Molecular Biology | 10 | 7% |
| Chemistry | 7 | 5% |
| Other | 20 | 14% |
| Unknown | 40 | 27% |