Physiologically-based pharmacokinetic model for Fentanyl in support of the development of Provisional Advisory Levels

Physiologically based pharmacokinetic modeling of human exposure to perfluorooctanoic acid suggests historical non drinking-water exposures are important for predicting current serum concentrations

“…When information on the distribution of a parameter was lacking, a medium CV and lognormal distribution were assumed as suggested previously, which resulted in a wider range of parameter values and model outputs (Zhang et al, 2007). Normal distributions, N(μ,σ 2 ) with mean μ and standard deviation σ, were assumed for the mass of protein in the proximal tubule cells ( protein ), the volume of the liver ( VLC ), and the volume of the filtrate ( VfilC ) (Tan et al, 2006; Allen et al, 2007; Mielniczuk et al, 2008; Delanaye et al, 2012; Shankaran et al, 2013). Lower and upper bounds for normally distributed parameters were calculated as μ ± 1.96σ (95% of the distribution).…”

“…For simulation of the exposure occurring in the Mid-Ohio Valley, body weights for adults aged 20 years and older as reported in the National Health and Nutrition Examination Survey (NHANES) (Ogden et al, 2004) were truncated at the 2.5th and 97.5th percentiles and used to determine the 95% distribution for this parameter (Tan et al, 2006; Shankaran et al, 2013; Sterner et al, 2013). For simulation of the exposure occurring in North Alabama, measured body weights (ATSDR, 2016a) were used to determine the probabilistic distribution.…”

“…Probabilistic distributions for Vmax_apical_invitro and Km_apical were determined using standard deviations reported in the literature (Nakagawa et al, 2007; Yang et al, 2010). A CV of 20% was used to determine the distribution for PL , while a CV of 30% was used to determine the distributions for all other chemical specific parameters (Delic et al, 2000; Tan et al, 2006; Shankaran et al, 2013). …”

Development of a Novel Oral Cavity Compartmental Absorption and Transit Model for Sublingual Administration: Illustration with Zolpidem

“…modeling was used to analyze absorption kinetics from the oral cavity to the systemic circulation [6,7]. More recently, the GastroPlus™ (Simulation Plus, Lancaster, CA) Advanced Compartmental Absorption and Transit (ACAT™) model and acslX (Aegis Technologies, Huntsville, AL) models were used to simulate the clinical pharmacokinetics of propranolol and fentanyl sublingual tablets, respectively [8,9]. However, all previously reported IO PK models used a simple firstorder absorption rate process without sufficiently linking oral cavity physiology and drug physicochemical properties.…”

A physiologically based pharmacokinetic model for quinoxaline‐2‐carboxylic acid in rats, extrapolation to pigs

“…Monte Carlo analysis can be incorporated into the PBPK model to predict accurately chemicals' residue withdrawal time in edible tissues in swine (Buur et al, 2006;Yang et al, 2012). Moreover, PBPK modeling can address gaps in the available toxicity data by enabling extrapolations across doses and exposure routes (Poet et al, 2004;Shankaran et al, 2013).…”