Assessment on Efficiency of Drug Delivery via ET(p) Under Nonlinear Mixed Effects Models

• Activity Number: 353
• Type: Contributed
• Date/Time: Tuesday, August 6, 2013 : 10:30 AM to 12:20 PM
• Sponsor: Biopharmaceutical Section
• Author(s): Qianqiu Li*+ and Kedar Gokhale and Chao Wang and Dhammika Amaratunga
• Companies: Janssen Research & Development and Janssen Research & Development and Janssen Research & Development and Janssen Research & Development
• Keywords: Nonlinear models ; Mixed effects ; Drug delivery ; Efficiency index ; Release rate ; ET(p)

Abstract

The drug release profiles are often examined using release rate data collected at multiple times. Different techniques and methods may be employed for comparisons and optimization of the efficiency of drug delivery. In this paper, under nonlinear models: weibull, logistic, exponential and gumbel models, we propose a generalized quantity: ET(p) (time to p% of maximum release) to assess the efficiency of drug delivery. Comparisons of delivery efficiency are implemented via estimation and statistical tests of relative efficiency index: ratio of ET(p)'s between two delivery groups. The nonlinear models include a random coefficient to account for variability across replicates per delivery group. The association between model constraints and group-specific ET(p)'s and between-group ET(p) ratios are investigated. Conclusive recommendations regarding models and model constraints are provided on the basis of simulation given different patterns of release profiles.