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Trends in safety pharmacology: Posters presented at the annual meetings of the safety pharmacology society 2001-2010.
MedLine Citation:
PMID:  21635957     Owner:  NLM     Status:  Publisher    
Abstract/OtherAbstract:
INTRODUCTION: The inaugural meeting of the Safety Pharmacology Society (SPS) was in 2001, soon after ICH S7A had been adopted. The 10th anniversary is an appropriate opportunity to analyse trends in the science and themes of safety pharmacology, as reflected in posters presented at the annual meetings. METHODS: The source information was the poster abstract booklets from each of the first ten annual meetings. RESULTS: The number of posters rose steadily from 34 in 2001 to 201 in 2010. The proportion of posters containing in vitro data has remained constant throughout the decade at ~30%. In terms of organ functions, themes relating to the cardiovascular system (CVS) have always generated the majority of posters, remaining above 60% of the total for the last 6years. The dominant theme has been around 'QT liability'. This peaked in 2003 at 68% of all posters presented, around the time of the ICHS7B discussions, and has remained above 30% thereafter. Apart from 2003 (dipping to 4%), CNS-related posters have remained steady at 11-17% throughout the decade. Respiratory-related posters have remained at 5-8% over the last 5years. Gastrointestinal (GI)-related posters have contributed 2-6% throughout the decade, and renal-related posters 1-3%. Posters on combined organ assessments have appeared in recent years. The relative emphasis on the different organ functions is broadly proportional to the causes of candidate drug attrition preclinically, whereas both CNS and GI are under-represented when considering their contribution to significant adverse effects during clinical development. DISCUSSION: Trends are either regulatory-driven (e.g. increase in posters on abuse-dependence liability since EMEA/CHMP/SWP/94227/2004), technology-driven (e.g. automated hERG assay; left ventricular function; non-invasive CVS measurements; stem cells, etc.), or relate to the predictive ability of safety pharmacology data (e.g. clinical translation initiatives; concordance between in vitro and in vivo preclinical data; integrated risk assessment; PK-PD relationships, etc.).
Authors:
William S Redfern; Jean-Pierre Valentin
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Publication Detail:
Type:  JOURNAL ARTICLE     Date:  2011-5-25
Journal Detail:
Title:  Journal of pharmacological and toxicological methods     Volume:  -     ISSN:  1873-488X     ISO Abbreviation:  -     Publication Date:  2011 May 
Date Detail:
Created Date:  2011-6-3     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  9206091     Medline TA:  J Pharmacol Toxicol Methods     Country:  -    
Other Details:
Languages:  ENG     Pagination:  -     Citation Subset:  -    
Copyright Information:
Copyright © 2011 Elsevier Inc. All rights reserved.
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