Pharma Research and Development

Medicinal plants are inexhaustible sources from which many of today’s most be useful drugs have been developed. While the majority of plant-based drugs are new (single) chemical entities (NCEs), a category of botanical drugs has recently reappeared in the US. Botanical drugs are defined as finished drugs for which the active ingredient is a complex, polymolecular drug substance. Although the criterion of adequate and well-controlled [clinical] studies remains a basis of new drug approval for the United States, botanical products pose unique challenges to clinical development due to their complex nature. This session will describe the clinical development of botanical drugs, with a focus on the US market. It will touch upon the differences between botanicals and NCEs and how these differences impact the types, designs, and even the timeline of clinical studies conducted for US drug development. Through examples, it will also relate some of the hurdles posed by complex botanical drugs which have been experienced in clinical studies of these products-both in research and in regulatory settings.