Special Populations in Clinical Pharmacology Studies: Evolving Challenges. (May 2017)

• Record Type: Journal Article
• Authors: Smith, William B.; Alcorn, Harry
• Is Part Of: Therapeutic innovation & regulatory science. Volume 51:Number 3(2017:May)
• Page Start: 285
• Page End: 287
• Publication Date: 2017-05
• Subjects: clinical pharmacology -- specialty populations -- drug metabolism; Drugs -- Periodicals; Pharmacology -- Periodicals; Drugs -- Research -- Periodicals; Drugs -- Testing -- Periodicals; 615.1
• DOI: 10.1177/2168479017706512
• Languages: English
• ISSNs: 2168-4790

Abstract

The clinical research industry is changing, and the number of protocols requiring specialty populations for early-phase clinical studies is increasing. In particular, the demand for studies on renal specialty populations has grown, given the prominent role of the renal system in excreting drugs from the body. Understanding the challenges associated with the use of specialty populations is critical to ensure that the study design will allow for the timely and successful completion of the project, while minimizing costs and safety risks.