Safety pharmacology methods and models in an evolving regulatory environment.

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.

authors

Pugsley MK,de Korte T,Authier S,Huang H,Accardi MV,Curtis MJ

doi

10.1016/j.vascn.2017.04.012

subject

Has Abstract

pub_date

2017-09-01 00:00:00

pages

1-6

eissn

1056-8719

issn

1873-488X

pii

S1056-8719(17)30097-7

journal_volume

87

pub_type

社论
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