Thompson Charles, Lombardi Don, Sjostedt Philip, Squires Liza
1 Pfizer Inc, New York, NY, USA.
2 Institute for Pediatric Innovation, Cambridge, MA, USA.
Ther Innov Regul Sci. 2015 Sep;49(5):647-658. doi: 10.1177/2168479015573585.
The palatability of oral drugs influences patient adherence to prescribed regimens, especially for children. Various factors influence palatability, including smell, taste, texture, and dose volume. Evaluation of these factors plays an important role in pediatric drug development and is a target for regulatory scrutiny. The Global Alliance for Pediatric Therapeutics, a public-private consortium under the guidance of the Institute for Pediatric Innovation, convened the Alliance Palatability Working Group to discuss the issues related to the assessment of palatability in the development of pediatric oral dosage forms. An extensive scientific literature search was conducted, in addition to a multicompany industry survey and a series of workshops with the Alliance Palatability Working Group. Based on the results, 3 best practice recommendations emerged regarding the assessment of palatability for oral dosage forms in pediatric drug development. These best practice recommendations offer researchers guidance for the preclinical and clinical assessment of palatability of oral dosage forms and serve to operationalize the assessment process within the overall drug development program.
口服药物的适口性会影响患者对规定治疗方案的依从性，对儿童而言尤其如此。多种因素会影响适口性，包括气味、味道、质地和剂量体积。对这些因素的评估在儿科药物研发中起着重要作用，也是监管审查的目标。全球儿科治疗联盟是一个在儿科创新研究所指导下的公私合营财团，召集了联盟适口性工作组来讨论儿科口服剂型研发中与适口性评估相关的问题。除了多公司行业调查以及与联盟适口性工作组举办的一系列研讨会之外，还进行了广泛的科学文献检索。基于这些结果，就儿科药物研发中口服剂型适口性评估提出了3条最佳实践建议。这些最佳实践建议为研究人员提供了关于口服剂型适口性临床前和临床评估的指导，并有助于在整个药物研发项目中实施评估过程。
