Literature DB >> 31158459

Response of safety pharmacologists to challenges arising from the rapidly evolving changes in the pharmaceutical industry.

Alan S Bass1, Michael K Pugsley2, Frederick Sannajust3, Takashi Yoshinaga4, Jean-Pierre Valentin5.   

Abstract

This commentary highlights and expands upon the thoughts conveyed in the lecture by Dr. Alan S. Bass, recipient of the 2017 Distinguished Service Award from the Safety Pharmacology Society, given on 27 September 2017 in Berlin, Germany. The lecture discussed the societal, scientific, technological, regulatory and economic events that dramatically impacted the pharmaceutical industry and ultimately led to significant changes in the strategic operations and practices of safety pharmacology. It focused on the emerging challenges and opportunities, and considered the lessons learned from drug failures and the influences of world events, including the financial crisis that ultimately led to a collapse of the world economies from which we are now recovering. Events such as these, which continue to today, challenge the assumptions that form the foundation of our discipline and dramatically affect the way that safety pharmacology is practiced. These include the latest scientific and technological developments contributing to the design and advancement of safe medicines. More broadly, they reflect the philosophical mission of safety pharmacology and the roles and responsibilities served by safety pharmacologists. As the discipline of Safety Pharmacology continues to evolve, develop and mature, the reader is invited to reflect on past experiences as a framework towards a vision of the future of the field.
Copyright © 2019 Elsevier Inc. All rights reserved.

Entities:  

Keywords:  Attrition; Cardiac; Central nervous system; Drug failure; QT prolongation; Regulatory; Society; hERG

Mesh:

Year:  2019        PMID: 31158459     DOI: 10.1016/j.vascn.2019.106593

Source DB:  PubMed          Journal:  J Pharmacol Toxicol Methods        ISSN: 1056-8719            Impact factor:   1.950


  1 in total

Review 1.  Monitoring haemodynamic changes in rodent models to better inform safety pharmacology: Novel insights from in vivo studies and waveform analysis.

Authors:  Marieke Van Daele; Samantha L Cooper; Patrizia Pannucci; Edward S Wragg; Julie March; Iwan de Jong; Jeanette Woolard
Journal:  JRSM Cardiovasc Dis       Date:  2022-05-23
  1 in total

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