The Role of Metabolites in Bioequivalency Assessment. III. Highly Variable Drugs with Linear Kinetics and First-Pass Effect

Role of metabolites for drugs that under

Role of metabolites for drugs that undergo nonlinear first-pass effect: Impact on bioequivalency assessment using single-dose simulations

✍ April C. Braddy; Andre J. Jackson 📂 Article 📅 2010 🏛 John Wiley and Sons 🌐 English ⚖ 280 KB

We investigated the effects of dose and intrasubject variability (ISV) on bioequivalence (BE) of a parent drug with a single metabolite formed by nonlinear firstpass. A BE simulation was done using a four-compartment model at doses of 17.5, 35.0, and 70.0 mg. ISV was set at either 10% or 20% for cle