Origins, practices and future of safety pharmacology
Origins, practices and future of safety pharmacology
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DOI：
10.1016/j.vascn.2004.02.007
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发表时间：
2004-05-01
影响因子：
1.9
通讯作者：
Williams, Patricia
中科院分区：
文献类型：
--
作者：
Bass, Alan;Kinter, Lewis;Williams, Patricia
安全药理学的起源基于以下观察结果：器官功能（如器官结构）可能是暴露于新型治疗药物的人体的毒理学靶点，并且标准毒理学试验不易检测到药物对器官功能（与器官结构不同）的影响。安全药理学是“…研究物质对生理功能的潜在不良药效学作用的研究。暴露在治疗范围及以上“（国际协调会议（ICH）S7 A指南;人用药物安全药理学研究）。本出版物全面回顾了安全药理学的历史，管理这一重要领域实践的国际监管指南，以及其在制药开发中迅速出现所面临的科学挑战。在非临床模型中识别新药的非预期不良反应的关键性反映了对可能的人类风险进行综合和准确评估的重要性。制定可靠的风险评估的挑战所带来的难题是改善和加强新药上市的安全进展的重要性，同时防止不必要的延迟（或停药），基于临床反应或人类风险方面不相关或不可解释的非临床结果。(C)2004爱思唯尔公司All rights reserved.
The origins of safety pharmacology are grounded upon observations that organ functions (like organ structures) can be toxicological targets in humans exposed to novel therapeutic agents, and that drug effects on organ functions (unlike organ structures) are not readily detected by standard toxicological testing. Safety pharmacology is "...those studies that investigate the potential undesirable pharmacodynamic effects of a substance on physiological functions in relationship to. exposure in the therapeutic range and above..." (International Conference on Harmonization (ICH) S7A guidelines; Safety Pharmacology Studies for Human Pharmaceuticals). This publication provides a comprehensive review of the history of safety pharmacology, international regulatory guidelines that govern the practices of this important field, and the scientific challenges that are being faced by its rapid emergence in pharmaceutical development. The criticality of identifying undesired adverse effects of new drugs in nonclinical models, which reflect the overall human condition, is reflected in the importance of generating an integrated and accurate assessment of possible human risk. The conundrum posed by the challenge of formulating a reliable risk assessment is the importance of improving and enhancing the safe progression of new drugs to the marketplace, while preventing unnecessary delays (or discontinuances), based on nonclinical findings that are not relevant or interpretable in terms of clinical response or human risk. (C) 2004 Elsevier Inc. All rights reserved.