Expert Opin Drug Saf. 2010 Mar;9(2):365-78. doi: 10.1517/14740331003625577.
The keynote presentation of the Safety Pharmacology (SP) Society 9th Annual Meeting addressed the urgency, for pharmaceutical organizations, to implement strategies for effectively communicating drug risks to all concerned stakeholders and, in particular, the general public. The application of chronobiology to SP investigational protocols can improve the search of drug-induced adverse effects. The Distinguished Service Award Lecture reviewed a life-long journey through trials and tribulations in the quest of the ever-distant scientific truth. The revision process of Directive 86/609/EC for improving animal welfare should be conducted with the purpose of maintaining a fair balance among animal protection, human health and research imperatives in order to prevent the migration of pharmaceutical activities outside Europe. Additional topics of interest were the behavioral, metabolic and cardiovascular problems experienced by small animals housed at the standard laboratory temperature. A technology for the automated collection of blood and urine samples in rats implanted with telemetry sensors was presented. Non-clinical, clinical, regulatory and legal aspects of abuse liability were expertly reviewed. The 'degradability' of pharmaceuticals into environment-friendly chemicals should be an actively searched and optimized feature of future pharmaceuticals in order to prevent drug pollution of ecosystems. Transgenic and diseased animal models should be selected whenever they can facilitate the determination of drug-induced adverse effects. SP strategies to investigate the safety of drug combination products were exemplified and analyzed in depth. The future of SP was proposed to lie not in the performance of regulatory studies of pharmacodynamic nature but in developing and early applying an array of screening assays for clearing clinical candidates against known drug-induced organ function injuries. In conclusion, the 2009 SP Society annual meeting offered a wealth of thought-provoking material to attendees for improving SP investigation strategies.
安全药理学(SP)学会第 9 届年会的主题演讲强调了制药企业迫切需要实施策略,以便有效地向所有相关利益攸关方,尤其是向公众传达药物风险。将时间生物学应用于 SP 研究方案可以提高药物不良反应的研究效果。杰出服务奖演讲回顾了毕生的探索历程,在寻求遥不可及的科学真理的过程中历经了考验和磨难。为了提高动物福利,应修订指令 86/609/EC,目的是在动物保护、人类健康和研究需求之间保持公平平衡,以防止制药活动向欧洲以外转移。其他相关议题包括标准实验室温度下饲养的小动物出现的行为、代谢和心血管问题。介绍了一种用于自动采集植入遥测传感器的大鼠血样和尿样的技术。滥用倾向的非临床、临床、监管和法律方面得到了专家的审查。为了防止药物对生态系统的污染,应积极寻求和优化将药物降解为环境友好型化学物质的特性。只要能促进确定药物不良反应,就应选择转基因和患病动物模型。对药物组合产品进行安全性研究的 SP 策略进行了举例说明和深入分析。提出 SP 的未来不在于进行药效学性质的监管研究,而在于开发和早期应用一系列筛选检测方法,以清除临床候选药物对已知药物诱导的器官功能损伤。总之,2009 年 SP 学会年会为与会者提供了大量发人深省的材料,以改进 SP 研究策略。