Linking Biophysical Functions of Microbicides to User Perception & Acceptability

将杀菌剂的生物物理功能与用户感知联系起来

基本信息

批准号：
7684100
负责人：
Kate M Guthrie
金额：
$ 43.88万
依托单位：
MIRIAM HOSPITAL
依托单位国家：
美国
项目类别：
财政年份：
2006
资助国家：
美国
起止时间：
2006-09-28 至 2011-08-31
项目状态：
已结题

项目摘要

DESCRIPTION (provided by applicant): This project directly addresses RFA-AI-06-005 request for technologies, strategies or models that contribute to new and more efficient ways of assessing and predicting microbicide acceptability within the preclinical framework of formulation development. Achieving this goal requires integration of behavioral with biophysical determinants of acceptability parameters. This project analyzes correspondence of cognitive and behavioral aspects of user ratings of microbicide characteristics and activity, with biophysical microbicide properties governing vaginal distribution/retention ("deployment") and hypothesized to correlate with human perceptions of microbicide use. During the R21 project, qualitative interviews, item development strategies and cognitive interviews will enable behavioral investigators to develop a user rating scale for use within the framework of preclinical feasibility studies of candidate microbicides. In parallel, formulation scientists will compute measures of biophysical functioning of 2 current over-the-counter vaginal gels, hypothesized to correlate with the behavioral constructs. Once it is shown that the behavioral tool (i.e., scale) has good psychometric characteristics, relationships between user rating measures and biophysical measures will be evaluated. Correspondence between what users can perceive/evaluate with respect to their experiences using a gel, and what biophysical properties/analysis can predict with respect to these perceptions and user ratings, will be delineated. The project goal is to demonstrate that these two measurement systems can be employed synergistically, toward optimization of 1) microbicide biophysical properties governing effective deployment and biofunctionality, and 2) user ratings of application- and vehicle-associated acceptability. In the R33 these measurement systems will be further evaluated and validated using novel GRAS gel formulations. Finally, a statistical framework that initiates prediction of user ratings of gels will be developed. The microbicide field's ability to co-determine microbicide function and acceptability will dramatically increase its ability to conceive and create optimal formulations in preclinical studies. By linking user ratings with biophysical properties, the resulting behavioral tool (scale) will better inform the preclinical microbicide pipeline, enabling products to be tailored to future users with greater certainty. In sum, this work will contribute methodology leading to rational design of microbicide formulations that co-optimize vaginal distribution and retention with user acceptability.

描述（由申请人提供）：该项目直接解决RFA-AI-06-005要求在配方开发的临床前框架内评估和预测微生物可接受性的新的，更有效的方法的技术，策略或模型。实现此目标需要将行为与可接受性参数的生物物理决定因素整合在一起。该项目分析了微生物特征和活性的用户评分的认知和行为方面的对应关系，生物物理菌糖的特性管理着阴道分布/保留率（“部署”），并假定与人类对菌心使用的看法相关。在R21项目中，定性访谈，项目开发策略和认知访谈将使行为研究人员能够开发一个用户评级量表，以在候选杀菌剂的临床前可行性研究框架内使用。同时，配方科学家将计算2种当前非处方阴道凝胶的生物物理功能的度量，假设与行为结构相关。一旦表明行为工具（即比例尺）具有良好的心理测量特征，将评估用户评分度量与生物物理措施之间的关系。用户可以使用凝胶对自己的经验感知/评估的对应关系，以及哪些生物物理属性/分析可以预测这些感知和用户评分的方法。项目的目标是证明这两个测量系统可以协同使用，以优化1）基于有效部署和生物功能的微生物生物物理特性，以及2）应用程序和车辆相关可接受性的用户评分。在R33中，将使用新型的GRAS凝胶配方对这些测量系统进行进一步评估和验证。最后，将开发一个启动凝胶用户评分预测的统计框架。微生物领域共同确定性微生物功能和可接受性的能力将大大提高其在临床前研究中的受孕和创造最佳制剂的能力。通过将用户评分与生物物理属性联系起来，所得的行为工具（比例）将更好地告知临床前微生物管道，从而使产品能够更确定地为未来的用户量身定制。总而言之，这项工作将有助于方法，从而导致合理设计菌皮制剂，从而将阴道分布和保留率与用户的可接受性合作。