Version 2.1.0.0

Abstract

Abstract: 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.

Thesaurus Terms:
alternative medicine, biotherapeutic agent, drug design /synthesis /production, drug quality /standard, plant extract, plant physiology
chemical synthesis, flavone, lignan, pharmacokinetics
high performance liquid chromatography, laboratory rat, protein purification

Institution:	NATURAL PHARMACIA INTERNATIONAL, INC.
	115 MILL ST
	BELMONT, MA 02478
Fiscal Year:	2002
Department:
Project Start:	20-SEP-2001
Project End:	30-JUN-2004
ICD:	NATIONAL CENTER FOR COMPLEMENTARY & ALTERNATIVE MEDICINE
IRG:	ZAT1