Development of Standardized Milk Thistle Product

描述（由申请人提供）：该I期和II期快速通道申请的目的是开发标准化的奶蓟产品，并确保未来基础和临床研究的质量受控和可靠来源。Natural Pharmacia International，Inc是一家成熟的天然产品实验室，已经建立了一个优秀的财团团队，按照FDA的指导方针建立标准化的奶蓟产品。该计划成功的关键在于植物鉴定、栽培、天然产物化学、化学合成和分析、质量保证和控制、毒性评价、生物利用度和药代动力学分析、体外和体内肝病模型、制定和监管问题，包括DMS（药物主文件）和IND（研究性新药）备案。此外，NPI还提出了一项出色的商业计划，其中包括水飞蓟种子提取物的来源，GMP生产和包装，储存，库存以及III期标准化产品和安慰剂的分销。拟议的商业应用：这项研究可能会导致一个标准化的牛奶蓟产品的发展，用于治疗肝脏疾病

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