| Literature DB >> 28621446 |
Abstract
Numerous selective androgen receptor modulators (SARMs) with differing chemical structures and nearly ideal pharmacological and pharmacokinetic properties have been developed that are well tolerated and selectively increase lean body mass in humans. However, definitive demonstration of the linkage between lean body mass and physical function in a relevant, large patient population has remained elusive for a SARM. The clinical endpoints serving as their basis of approval have shifted with time and clinical indication and are likely to continue to do so as the field matures with additional safety and efficacy data pertaining to the relationship between lean body mass and physical function, regulatory decisions with SARMs and other agents, and yet unexplored clinical indications.Entities:
Keywords: clinical trials; drug development; lung cancer; oncology; phase I; statistics and study design
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Year: 2017 PMID: 28621446 PMCID: PMC5595949 DOI: 10.1111/bcp.13345
Source DB: PubMed Journal: Br J Clin Pharmacol ISSN: 0306-5251 Impact factor: 4.335