Review considerations on the design and evaluation of the oral sensory features in pediatric medications
10.16438/j.0513-4870.2023-0488
- VernacularTitle:儿童用药口感研究设计与评价的审评考虑
- Author:
Yan-zhe SUN
;
Duan-duan CONG
;
Ying GENG
;
Zhi-min YANG
- Publication Type:Research Article
- Keywords:
pediatric medication;
oral sensory feature;
swallowability;
palatability;
esign;
evaluation
- From:
Acta Pharmaceutica Sinica
2023;58(11):3160-3164
- CountryChina
- Language:Chinese
-
Abstract:
Recent years, China has released a series of policies to encourage drug research and development in pediatric populations, aiming to meet pediatric populations' medical needs. Because of the physical and psychological developmental characteristics, tolerance of aversive feelings when taking medications are different between pediatric population and adults. So pediatric populations are at a relatively higher risk of not taking medications as prescribed when the medication tasted unpleasant. Therefore, sound design and evaluation of oral sensory features have important clinical significance and value in developing pediatric medications. "Technical guidance for the design and evaluation of the oral sensory features of pediatric drugs (trial version) " was released in November 2022, by Centre for Drug Evaluation, National Medical Products Administration of China. Based on the guidance, this article will introduce the drafting background and review considerations, hoping to provide reference for the design and evaluation of oral sensory features, and promote drug developing in pediatric population.
