J. Steven Leeder

Dec 20, 2023 | ascpt.onlinelibrary.wiley.com | Shen Cheng |Mahmoud Al-Kofahi |J. Steven Leeder |Therapeutic Innovation

Atomoxetine (ATX) is a non-stimulant used to treat attention-deficit/hyperactivity disorder (ADHD) and systemic exposure is highly variable due to polymorphic cytochrome P450 2D6 (CYP2D6) activity. The objective of this study was to characterize the time course of ATX and metabolites (4-hydroxyatomoxetine, 4-OH; N-desmethylatomoxetine, NDA; and 2- carboxymethylatomoxetine, 2-COOH) exposure following oral ATX dosing in ADHD children to support individualized dosing.

Nov 6, 2023 | dmd.aspetjournals.org | Stephani Stancil |Robin Pearce |Vincent S. Staggs |J. Steven Leeder

AbstractScaling factors are necessary for translating in vitro drug biotransformation data to in vivo clearance values in physiologically-based pharmacokinetic modeling and simulation. Values for microsomal protein per gram of liver are available from several sources for use as a scaling factor to estimate hepatic clearance from microsomal drug biotransformation data.

Sep 21, 2023 | dmd.aspetjournals.org | Stephani Stancil |Robin Pearce |Vincent S. Staggs |J. Steven Leeder

AbstractScaling factors are necessary for translating in vitro drug biotransformation data to in vivo clearance values in physiologically-based pharmacokinetic (PBPK) modeling and simulation. Values for microsomal protein per gram of liver (MPPGL) are available from several sources for use as a scaling factor to estimate hepatic clearance from microsomal drug biotransformation data.