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首页> 外文期刊>The Journal of toxicological sciences >Essentials for starting a pediatric clinical study (4):Clinical pediatric safety planning based on preclinical toxicity studies and pediatric pharmacovigilance guidance
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Essentials for starting a pediatric clinical study (4):Clinical pediatric safety planning based on preclinical toxicity studies and pediatric pharmacovigilance guidance

机译：起始儿科临床研究的必需品（4）：基于临床前毒性研究和儿科药理治指导的临床儿科安全规划

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Juvenile toxicology studies in animals provide useful information to guide monitoring of potential adverse effects in children especially on growth and development. In order to continue to gain knowledge and build upon these preclinical studies, recent experience has suggested that additional approaches for monitoring of safety concerns in the pediatric population may be required. Recently, pediatric guidance has become available from the health authorities which provide pharmacovigilance concepts as they specifically relate to drugs being developed for pediatric indications. Clinical trials are typically not robust enough to detect rare or delayed safety effects as the pediatric trials are relatively short-term. Furthermore, such long term or rare effects may not be detected via standard voluntary post-marketing surveillance. Safety monitoring of children with Juvenile Inflammatory Arthritis (JIA) taking nonsteroid anti-inflammatory drug (NSAID)s will be used as an example to describe a post-marketing risk management and pharmacovigilance program that serves to better evaluate safety data from various sources. The intent of this program is to identify adverse events (AE), including events with longer latency, which may be associated with NSAID use in a pediatric population. In this presentation, the 4 major components of the program are to be addressed. Such a program may serve as a model to proactively generate and monitor safety data in order to identify AEs that may be associated with new therapeutics for a pediatric population.
机译：动物中的少年毒理学研究提供了指导对儿童潜在不利影响的有用信息，尤其是在增长和发展上。为了继续获得这些临床前研究的知识和建立，最近的经验表明，可能需要额外的额外方法监测儿科人口中的安全问题。最近，儿科指导已从卫生当局获得，这些卫生当局提供药剂检察概念，因为他们与被开发的儿科指示开发的药物有关。临床试验通常不足以检测稀有或延迟的安全效果，因为儿科试验相对短期。此外，可能无法通过标准自愿营销监测检测这种长期或罕见的效果。采用非甾醇炎症性关节炎的儿童的安全监测（jia）以非甾醇抗炎药（NSAID）S将被用作描述用于更好地评估各种来源的安全数据的营销售前风险管理和药物知识计划的示例。该程序的目的是识别不良事件（AE），包括具有更长延迟的事件，这可能与儿科人群中的NSAID使用相关联。在本演示文稿中，将解决该计划的4个主要组成部分。这样的程序可以用作主动生成和监测安全数据的模型，以识别可能与儿科人群的新治疗剂相关的AES。

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