Development of Standardized Milk Thistle Product

描述（由申请人提供）：本阶段I和II的目的是快速 跟踪应用是开发标准化的奶蓟产品， 确保未来基础和临床的质量控制和可靠的来源 问题研究Natural Pharmacia International，Inc是一家成熟的天然产品 实验室，建立了一个优秀的财团团队，建立了一个 标准化的奶蓟产品遵循FDA的指导方针。的关键 这个计划的成功，因为它已经设想，是合作的努力， 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 体外和体内评价、生物利用度和药代动力学分析 肝病模型、制剂和监管问题，包括DMS（药物 主文件）和IND（研究性新药）备案。此外，NPI 提出了一个出色的商业计划，其中包括牛奶的来源 蓟籽提取物，GMP生产和包装，储存，库存，和 III期标准化产品和安慰剂的分布。 拟定商业应用： 这项研究可能会导致一个标准化的奶蓟产品的发展， 肝脏疾病的治疗。

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.