chapter  20
28 Pages

Nutraceutical Clinical Batch Manufacturing

Application........................................................................................ 524 20.4 Clinical Development ................................................................................... 525

20.4.1 Clinical Trials Management and Types ............................................ 525 20.4.2 Phase I Clinical Trial ........................................................................ 525 20.4.3 Phase II Clinical Trial....................................................................... 525 20.4.4 Phase III Clinical Trial ..................................................................... 525 20.4.5 New Drug Application ...................................................................... 526 20.4.6 Phase IV Clinical Trial ..................................................................... 526

20.1 INTRODUCTION

The word nutraceutical was first introduced in 1989 by Stephen DeFelice, founder and chair of the Foundation for Innovation in Medicine (Brower 1998). Nutraceutical is a combination of “nutrition” and “pharmaceutical” and is defined as “a food (or part of a food) that provides health benefits and fitness, including the prevention of some approved structure/function claims and/or the common, non-serious ‘life stages’ symptoms” (Zeisel 1999, p. 1853). Today, nutraceuticals are widely manufactured because of the significant increase in the public demand. Several clinical studies have been done for nutraceuticals. Good and qualified clinical manufacturing is critical. In this chapter, I will focus on the clinical trials, good manufacturing practice, and future development of nutraceuticals.