Year: 2012
Type: article
Abstract: Therapeutic development includes the activities necessary to bring a new medicinal compound (chemical or biologic) or medical device to market. Following drug discovery or development of a new device, successful preclinical studies result in an Investigational New Drug (IND) application (United States only; Clinical Trials Exemption Certificate in the United Kingdom). Once the IND is filed, a team-driven process begins that tests the efficacy and safety of a new therapeutic in humans. This process, known as clinical development, has traditionally been divided into 4 phases, with large-scale phase 3 pivotal trials in patients with a specific disease leading to registration and postmarketing studies.1 The authors thank Daniel Benjamin, MD, and Paul Watkins, MD, for their critical review of the manuscript.
Source: Neurology
Language: English
Subfield: Statistics and Probability
Field: Mathematics
Domain: Physical Sciences
Open Access status: bronze
OpenAlex ID: W2139203507