chapter  12
22 Pages

Evidence-Based Medicine, Safety, and Efficacy

Clinical Trial Management in Botanical Drug Products
WithAva Milani, Yashwant Pathak

Botanical drug products are products that include plant materials, algae, macroscopic fungi, and combinations thereof (1). The development and consumption of botanical drug products have increased in United States in last two decades and has become an important tool in the fight against many deadly chronic diseases. This chapter reviews botanical drug products and their development, specifically within the United States. The chapter will also discuss the role of the evidence-based (medicine) approach in botanical drug products and clinical trial management and optimization of clinical trial management budgeting. Safety and efficacy of botanical drug products is shown through discussion of the Food and Drug Administration’s (FDA) guidance for development.