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
ACKNOWLEDGMENT
The authors thank Daniel Benjamin, MD, and Paul Watkins, MD, for their critical review of the manuscript.
Footnotes
Go to Neurology.org for full disclosures. Funding information and disclosures deemed relevant by the authors, if any, are provided at the end of the article.
- © 2012 American Academy of Neurology
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