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- W2034896758 abstract "There is an increasing interest in the simultaneous administration of several probe substrates to characterize the activity of multiple drug‐metabolizing enzymes, the so‐called “cocktail” approach. However, this method remains controversial and is being investigated more extensively. No general consensus has emerged on the applicability of this approach in clinical investigation and during drug development. The objective of the article is to review this important yet specialized technique, as well as its merits, drawbacks, and potential application in drug development. Among the two‐, three‐, four‐, five‐, and six‐drug in vivo cocktails previously evaluated in humans, a variety of substrate probe combinations have been studied. Some probe combinations have been validated not to interact in vivo and have been useful in characterizing drug‐drug interaction potential and metabolic enzyme induction in humans. For drug candidates that affect two or more in vitro pathways or are potential gene inducers, the use of a cocktail approach may facilitate the rapid delineation of the drug candidate's drug interaction potential. It may also offer the potential of providing clear guidance on safely conducting larger clinical studies and limiting comedication restrictions to only those likely to be clinically relevant." @default.
- W2034896758 created "2016-06-24" @default.
- W2034896758 creator A5031629161 @default.
- W2034896758 creator A5052635590 @default.
- W2034896758 creator A5074043509 @default.
- W2034896758 date "2004-02-01" @default.
- W2034896758 modified "2023-10-17" @default.
- W2034896758 title "“Cocktail” Approaches and Strategies in Drug Development: Valuable Tool or Flawed Science?" @default.
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- W2034896758 doi "https://doi.org/10.1177/0091270003261333" @default.
- W2034896758 hasPubMedId "https://pubmed.ncbi.nlm.nih.gov/14747420" @default.
- W2034896758 hasPublicationYear "2004" @default.
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