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J Pharmacol Toxicol Methods. 2017 Sep;87:1-6. doi: 10.1016/j.vascn.2017.04.012. Epub 2017 Apr 29.

Safety pharmacology methods and models in an evolving regulatory environment.

Author information

1
Department of Toxicology & PKDM, Purdue Pharma LP, 201 Tresser Blvd., Stamford, CT 06901, United States. Electronic address: michael.pugsley@pharma.com.
2
Pluriomics B.V., Biopartner Building 3, Galileiweg 8, Leiden 2333 BD, The Netherlands.
3
CiToxLAB Research Inc., 445 Armand Frappier, Laval, QC H7V 4B3, Canada.
4
Cardiovascular Division, Rayne Institute, St Thomas' Hospital, London SE17EH, UK.

Abstract

This editorial prefaces the annual themed issue on safety pharmacology (SP) methods published in the Journal of Pharmacological and Toxicological Methods (JPTM). We highlight here the content derived from the recent 2016 Safety Pharmacology Society (SPS), Canadian Society of Pharmacology and Therapeutics (CSPT), and Japanese Safety Pharmacology Society (JSPS) joint meeting held in Vancouver, B.C., Canada. This issue of JPTM continues the tradition of providing a publication summary of articles primarily presented at the joint meeting with direct bearing on the discipline of SP. As the regulatory landscape is expected to evolve with revision announced for the existing guidance document on non-clinical proarrhythmia risk assessment (ICHS7B) there is also imminent inception of the Comprehensive in vitro Proarrhythmia Assay (CiPA) initiative. Thus, the field of SP is dynamically progressing with characterization and implementation of numerous alternative non-clinical safety models. Novel method development and refinement in all areas of the discipline are reflected in the content.

PMID:
28461240
DOI:
10.1016/j.vascn.2017.04.012
[Indexed for MEDLINE]

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