Development of Standardized Milk Thistle Product

描述(由申请人提供)：第一阶段和第二阶段FAST的目标 跟踪应用是开发标准化的牛奶蓟产品，并 确保为未来的基础和临床提供受质量控制的可靠来源 学习。天然药典国际公司，久负盛名的天然产品 实验室，建立了一支优秀的财团团队，建立了 标准化牛奶蓟产品遵循FDA的指导方针。解决问题的关键是 这项计划的成功有赖于以下人员的共同努力 植物学鉴定、栽培、天然产物化学方面的专家， 化学合成与分析、质量保证与控制、毒性 体内外评价、生物利用度和药代动力学分析 肝病模型、配方和监管问题，包括DMS(药物 主文件)和IND(研究新药)申请。此外，NPI 提出了一份出色的商业计划，其中包括牛奶的来源 百里香籽提取物、GMP制造和包装、储存、库存和 标准化产品和安慰剂在第三阶段的分配。 建议的商业应用： 这项研究可能会导致开发一种标准化的水飞蓟产品 肝病的治疗。

DESCRIPTION (Provided by applicant): The objective of this Phase I and II fast track application is to develop a standardized milk thistle product and to assure a quality controlled and reliable source for future basic and clinical studies. Natural Pharmacia International, Inc, an established natural products laboratory, has established an excellent consortial team to establish a standardized milk thistle product following FDA guidelines. The key to the success of this program as it has been conceived, is the cooperative efforts of experts in botanical identification, cultivation, natural products chemistry, chemical synthesis and analysis, quality assurance and control, toxicity evaluation, bioavailability and pharmacokinetics analysis, in vitro and in vivo liver disease models, formulation and regulatory issues including DMS (drug master file) and IND (investigational new drug) filing. In addition, NPI proposed an outstanding business plan, which includes the source of the milk thistle seed extract, GMP manufacturing and packaging, storage, inventory, and distribution of the standardized product and placebo in Phase III. PROPOSED COMMERCIAL APPLICATION: This research may lead to the development of a standardized milk thistle product for treatment of liver diseases.