IN VITRO, IN VIVO, ACOUSTIC CHARACTERIZATION--AEROSOMES

描述（改编自申请人摘要）：诊断超声 在全球范围内每年有可能达到十亿美元的市场 的 申请人的具体目标和长期目标涉及发展 一种有效和低成本的超声造影剂， 图像敏感性，使得申请人认为可以成为 用于各种诊断程序的工业标准（即， 肝脾成像、心脏成像和室壁运动研究、血液- 池成像[血管瘤]和血管流动研究）。 研究 方法学将涉及关键的体外、体内和声学 表征研究，以帮助申请组织，ImaRx 制药，在确定其应用的潜力。 的 这项研究的意义可以提供一种方法， 由于使用诊断成像，降低了医疗保健成本 气溶胶与超声波可能成为一个高品质， 可靠的替代现有的，更昂贵的，诊断程序 (MRI CT等）。 这可能对小型企业特别有益。 社区医院以及第三工作医疗保健机构， 超声雾化器可以提供高质量、低成本的 诊断保健。 第二阶段的目标将包括： 表征;有效期稳定性测定; 详细的药理学和毒理学;进行详细的 生物分布研究，进行进一步的成像研究，以及 启动I期临床试验计划。

DESCRIPTION (Adapted from Applicant's Abstract): Diagnostic ultrasound potentially represents a billion dollar a year market worldwide. The applicants' specific aims and longterm objective involve the development of an efficient and low-cost ultrasound contrast agent with improved image sensitivity such that the applicants believe could become the industry standard for a variety of diagnostic procedures (i.e. hepatosplenic imaging, cardiac imaging and wall-motion studies, blood- pool imaging [hemangiomas], and vascular flow studies). The research methodology would involve critical in vitro, in vivo, and acoustic characterization studies to aid the applicant organization, ImaRx Pharmaceutical, in determining the potential for it's application. The implications of the research could provide a means for substantially reduced health-care costs with regard to diagnostic imaging as the use of Aerosomes with ultrasound potentially could become a high quality and reliable alternative to existing, more costly, diagnostic procedures (MRI, CT, etc.). This could become particularly beneficial for small community hospitals as well as third work health care concerns as Aerosomes with ultrasound could provide high quality, low cost diagnostic healthcare. Goals of Phase II would include: acoustic characterization; shelf life stability determination; conduct of detailed pharmacology and toxicology; conduct of detailed biodistribution studies, conduct of further imaging studies, and initiate planning of Phase I clinical trials.