Methodological innovations expand the safety pharmacology horizon

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• 作者：M.K. Pugsley ; M.J. Curtis
• 关键词：hERG ; Lambeth conventions ; Arrhythmia ; Safety ; ICHS7A ; ICH S8
• 刊名：Journal of Pharmacological and Toxicological Methods
• 出版年：2012
• 出版时间：September-October, 2012
• 年：2012
• 卷：66
• 期：2
• 页码：59-62
• 全文大小：153 K

文摘

Almost uniquely in pharmacology, drug safety assessment is driven by the need for elaboration and validation of methods for detecting drug actions. This is the 9th consecutive year that the Journal of Pharmacological and Toxicological Methods (JPTM) has published themed issues arising from the annual meeting of the Safety Pharmacology Society (SPS). The SPS is now past its 10th year as a distinct (from pharmacology to toxicology) discipline that integrates safety pharmacologists from industry with those in academia and the various global regulatory authorities. The themes of the 2011 meeting were (i) the bridging of safety assessment of a new chemical entity (NCE) between all the parties involved, (ii) applied technologies and (iii) translation. This issue of JPTM reflects these themes. The content is informed by the regulatory guidance documents (S7A and S7B) that apply prior to first in human (FIH) studies, which emphasize the importance of seeking model validation.

The manuscripts encompass a broad spectrum of safety pharmacology topics including application of state-of-the-art techniques for study conduct and data processing and evaluation. This includes some exciting novel integrated core battery study designs, refinements in hemodynamic assessment, arrhythmia analysis algorithms, and additionally an overview of safety immunopharmacology, and a brief survey discussing similarities and differences in business models that pharmaceutical companies employ in safety pharmacology, together with SPS recommendations on ¡®best practice¡¯ for the conduct of a non-clinical cardiovascular assessment of a NCE.