Development of Standardized Milk Thistle Product

描述(由申请人提供)：第一阶段和第二阶段快速通道应用的目标是开发标准化的牛奶蓟产品，并为未来的基础和临床研究确保质量受控和可靠的来源。天然药典国际公司，一家老牌天然产品实验室，建立了一支优秀的联合团队，按照FDA的指导方针建立了标准化的牛奶蓟产品。这一计划成功的关键是在植物学鉴定、栽培、天然产物化学、化学合成和分析、质量保证和控制、毒性评估、生物利用度和药代动力学分析、体外和体内肝病模型、配方和监管问题(包括DMS(药物主文件)和IND(研究新药)备案)方面的专家的合作努力。此外，NPI提出了一项出色的商业计划，其中包括第三阶段水飞蓟种子提取物的来源、GMP制造和包装、标准化产品和安慰剂的储存、库存和分销。建议的商业应用：这项研究可能导致开发用于治疗肝病的标准化水飞蓟产品

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