* Drug Safety in Translational Paediatric Research: Practical Points to Consider for Paediatric Safety Profiling and Protocol Development: A Scoping Review.
- Translational paediatric drug development includes the exchange between basic, clinical and population-based research to improve the health of children. This includes the assessment of treatment related risks and their management. The objectives of this scoping review were to search and summarise the literature for practical guidance on how to establish a paediatric safety specification and its integration into a paediatric protocol. PubMed, Embase, Web of Science, and websites of regulatory authorities and learned societies were searched (up to 31 December 2020). Retrieved citations were screened and full texts reviewed where applicable. A total of 3480 publications were retrieved. No article was identified providing practical guidance. An introduction to the practical aspects of paediatric safety profiling and protocol development is provided by combining health authority and learned society guidelines with the specifics of paediatric research. The paediatric safety specification informs paediatric protocol development by, for example, highlighting the need for a pharmacokinetic study prior to a paediatric trial. It also informs safety related protocol sections such as exclusion criteria, safety monitoring and risk management. In conclusion, safety related protocol sections require an understanding of the paediatric safety specification. Safety data from carefully planned paediatric research provide valuable information for children, parents and healthcare providers.
=>供給する, 与える, 規定する, 条件とする, 準備する, 用意する, 扶養する, 援助する
Overview of verb provide
The verb provide has 7 senses (first 4 from tagged texts)
1. (270) supply, provide, render, furnish -- (give something useful or necessary to; "We provided
the room with an electrical heater")
2. (25) provide, supply, ply, cater -- (give what is desired or needed, especially support, food or
sustenance; "The hostess provided lunch for all the guests")
3. (14) provide -- (determine (what is to happen in certain contingencies), especially by including
a proviso condition or stipulation; "The will provides that each child should receive half of the
money"; "The Constitution provides for the right to free speech")
4. (2) put up, provide, offer -- (mount or put up; "put up a good fight"; "offer resistance")
5. leave, allow for, allow, provide -- (make a possibility or provide opportunity for; permit to be
attainable or cause to remain; "This leaves no room for improvement"; "The evidence allows only one
conclusion"; "allow for mistakes"; "leave lots of time for the trip"; "This procedure provides for
lots of leeway")
6. provide, bring home the bacon -- (supply means of subsistence; earn a living; "He provides for
his large family by working three jobs"; "Women nowadays not only take care of the household but
also bring home the bacon")
7. provide -- (take measures in preparation for; "provide for the proper care of the passengers on
the cruise ship")
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