赋形剂的筛选和仔细选择是儿科配方开发的关键步骤,因为某些赋形剂在成人配方中是可以接受的。可能不适合儿科使用。虽然有大量的毒性数据可以帮助更好地理解和突出毒性研究中的差距,数据通常分散在信息源周围,并带有不兼容的数据类型和格式。本文是Eu-USPFIs开发的儿科赋形剂的安全性和毒性(“STEP”)数据库的更新系列中的第二篇,并描述了数据库的架构数据字段和功能。STEP数据库是用户设计的资源,它编译了分散在各种来源上的赋形剂的安全性和毒性数据,并将其呈现在一个可自由访问的来源中。目前,在2000多个参考文献/10个临床前赋形剂的试点数据库数据中,临床,监管信息和毒理学审查,带有引用和源代码链接。STEP数据库允许搜索\"FOR\"赋形剂和\"BY\"赋形剂。STEP数据库的双重性质,可以双向搜索毒性和安全性信息,使其与现有来源不同。如果飞行员成功,目的是增加现有数据库中赋形剂的数量,以便有足够大的数据库可用于实际研究。预计该来源将被证明是用于赋形剂安全信息的数据管理和数据交换的有用平台。
The screening and careful selection of excipients is a critical step in paediatric formulation development as certain excipients acceptable in adult formulations, may not be appropriate for paediatric use. While there is extensive toxicity data that could help in better understanding and highlighting the gaps in toxicity studies, the data are often scattered around the information sources and saddled with incompatible data types and formats. This paper is the second in a series that presents the update on the Safety and Toxicity of Excipients for Paediatrics (\"STEP\") database being developed by Eu-US PFIs, and describes the architecture data fields and functions of the database. The STEP database is a user designed resource that compiles the safety and toxicity data of excipients that is scattered over various sources and presents it in one freely accessible source. Currently, in the pilot database data from over 2000 references/10 excipients presenting preclinical, clinical, regulatory information and toxicological reviews, with references and source links. The STEP database allows searching \"FOR\" excipients and \"BY\" excipients. This dual nature of the STEP database, in which toxicity and safety information can be searched in both directions, makes it unique from existing sources. If the pilot is successful, the aim is to increase the number of excipients in the existing database so that a database large enough to be of practical research use will be available. It is anticipated that this source will prove to be a useful platform for data management and data exchange of excipient safety information.