Safety pharmacology — Current and emerging concepts
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 studi...
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| Veröffentlicht in: | Toxicology and applied pharmacology 2013-12, Vol.273 (2), p.229-241 |
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| creator | Hamdam, Junnat Sethu, Swaminathan Smith, Trevor Alfirevic, Ana Alhaidari, Mohammad Atkinson, Jeffrey Ayala, Mimieveshiofuo Box, Helen Cross, Michael Delaunois, Annie Dermody, Ailsa Govindappa, Karthik Guillon, Jean-Michel Jenkins, Rosalind Kenna, Gerry Lemmer, Björn Meecham, Ken Olayanju, Adedamola Pestel, Sabine Rothfuss, Andreas Sidaway, James Sison-Young, Rowena Smith, Emma Stebbings, Richard Tingle, Yulia Valentin, Jean-Pierre Williams, Awel Williams, Dominic Park, Kevin Goldring, Christopher |
| description | 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.
•SP — mandatory non-clinical risk assessments performed during drug development.•SP organ system studies ensure the safety of clinical participants in FiH trials.•Frontloading in SP facilitates lead candidate drug selection.•Emerging trends: integrating SP-Toxicological endpoints; combined core battery tests. |
| doi_str_mv | 10.1016/j.taap.2013.04.039 |
| format | Article |
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•SP — mandatory non-clinical risk assessments performed during drug development.•SP organ system studies ensure the safety of clinical participants in FiH trials.•Frontloading in SP facilitates lead candidate drug selection.•Emerging trends: integrating SP-Toxicological endpoints; combined core battery tests.</abstract><cop>Amsterdam</cop><pub>Elsevier Inc</pub><pmid>23732082</pmid><doi>10.1016/j.taap.2013.04.039</doi><tpages>13</tpages></addata></record> |
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| identifier | ISSN: 0041-008X |
| ispartof | Toxicology and applied pharmacology, 2013-12, Vol.273 (2), p.229-241 |
| issn | 0041-008X 1096-0333 |
| language | eng |
| recordid | cdi_osti_scitechconnect_22285504 |
| source | MEDLINE; Elsevier ScienceDirect Journals |
| subjects | 60 APPLIED LIFE SCIENCES ALANINES ALKALINE PHOSPHATASE Animals Biological and medical sciences BIOLOGICAL MARKERS Cardiovascular CENTRAL NERVOUS SYSTEM CLINICAL TRIALS Drug Discovery - methods Drug Discovery - standards Drug Discovery - trends Drug Evaluation, Preclinical - methods Drug Evaluation, Preclinical - standards Drug Evaluation, Preclinical - trends Drug Interactions - physiology Drug-Related Side Effects and Adverse Reactions - metabolism Drug-Related Side Effects and Adverse Reactions - prevention & control GLUTATHIONE HEART Humans International Conference on Harmonisation KIDNEYS LACTATE DEHYDROGENASE Medical sciences NEUTROPHILS Pharmaceutical Preparations - metabolism Pharmaceutical Preparations - standards PHARMACOLOGY Respiratory Risk RISK ASSESSMENT SAFETY Safety pharmacology STEM CELLS Toxicology |
| title | Safety pharmacology — Current and emerging concepts |
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