Journal: CPT: Pharmacometrics & Systems Pharmacology
Article Title: A guide to developing population files for physiologically‐based pharmacokinetic modeling in the Simcyp Simulator
doi: 10.1002/psp4.13202
Figure Lengend Snippet: The input parameters required for a Simcyp population file are arranged in tabs as shown in the middle pane. The key tabs relevant to most populations are shown separately. The first tab contains the demographic parameters for the population (a), allowing the user to describe a relationship between age, height, and weight. The user‐defined functionality to define the distribution frequency (%) of population with respect to age in the Sim‐Japanese population (b). The user‐defined functionality to define the height and weight relationship for the Sim‐Morbidly Obese population (c). The Demographic tab (d) allows the input for all metabolism and transporter protein frequencies. The blood composition parameters are defined on a separate tab (e). For an orally administered drug, the required physiology data for the GI tract table (f) are automatically selected depending on the absorption model selected (first order, ADAM, or M‐ADAM). The Liver tab (g) contains the input parameters for the organ scalars (such as HPGL, MPPGL, and liver weight), the enterohepatic recirculation, and the metabolic and transporter protein phenotype and genotype population abundances and variabilities. The Kidney tab (h) allows the input of parameters required to estimate the population‐specific GFR for the age‐dependent serum creatinine plasma concentration, the organ scalar (such as MPPGK and kidney size), and the metabolic and transporter phenotype abundances and variabilities.
Article Snippet: The created CD population has been applied to two oral drug formulations: budesonide‐controlled release and midazolam solution modeled using the Simcyp ADAM absorption model with clinical studies in the CD population.
Techniques: Clinical Proteomics, Concentration Assay
