A General Framework for Assessing In vitro/In vivo Correlation as a Tool for Maximizing the Benefit-Risk Ratio of a Treatment Using a Convolution-Based Modeling Approach.

ABSTRACT: The net benefit of a treatment can be defined by the relationship between clinical improvement and risk of adverse events: the benefit-risk ratio. The optimization of the benefit-risk ratio can be achieved by identifying the most adequate dose (and/or dosage regimen) jointly with the best-performing in vivo release properties of a drug. A general in silico tool is presented for identifying the dose, the in vitro and the in vivo release properties that maximize the benefit-risk ratio using convolution-based modeling, an exposure-response model, and a surface response analysis. A case study is presented to illustrate how the benefit-risk ratio of methylphenidate for the treatment of attention deficit hyperactivity disorder can be maximized using the proposed strategy. The results of the anal

SUBMITTER: Gomeni R 

PROVIDER: S-EPMC6389349 | biostudies-literature | 2019 Feb

REPOSITORIES: biostudies-literature