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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概要
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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.
論文 | ランダム
- メタ・ヒューリスティックをベースにした時間割構築システムの研究
- 敏感なアリと鈍いアリによるアントコロニー最適化 (ニューロコンピューティング)
- 敏感なアリと鈍いアリによるアントコロニー最適化 (非線形問題)
- 最適性理論における心理学の影響--ヒューリスティックとバイアスについて
- メタヒューリスティックスの現状と課題 ([日本工業大学]情報工学科特集号 高度情報社会を担う情報技術のスペシャリストを育成) -- (情報工学科の研究活動)