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Tutorial on Model Selection and Validation of Model Input into Precision Dosing Software for Model ‐Informed Precision Dosing
AbstractThere has been rising interest in using model-informed precision dosing to provide personalized medicine to patients at the bedside. This methodology utilizes population pharmacokinetic models, measured drug concentrations from individual patients, pharmacodynamic biomarkers, and Bayesian estimation to estimate pharmacokinetic parameters and predict concentration-time profiles in individual patients. Using these individualized parameter estimates and simulated drug exposure, dosing recommendations can be generated to maximize target attainment to improve beneficial effect and minimize toxicity. However, the accurac...
Source: CPT: Pharmacometrics and Systems Pharmacology - September 29, 2023 Category: Drugs & Pharmacology Authors: Zachary L. Taylor, Ethan A. Poweleit, Kelli Paice, Katherine M. Somers, Kathryn Pavia, Alexander A. Vinks, Nieko Punt, Tomoyuki Mizuno, Sonya Tang Girdwood Tags: TUTORIAL Source Type: research

A Markov model of fibrosis development in Non ‐Alcoholic Fatty Liver Disease predicts fibrosis progression in clinical cohorts
AbstractDisease progression in non-alcoholic steatohepatitis (NASH) is highly heterogenous and remains poorly understood. Fibrosis stage is currently the best predictor for development of end-stage liver disease and mortality. Better understanding and quantifying the impact of factors affecting NASH and fibrosis is essential to inform clinical study design. We developed a population Markov model to describe the transition probability between fibrosis stages and mortality using a unique clinical non-alcoholic fatty liver disease (NAFLD) cohort with serial biopsies over three decades. We evaluated covariate effects on all mo...
Source: CPT: Pharmacometrics and Systems Pharmacology - September 26, 2023 Category: Drugs & Pharmacology Authors: Jane Kn öchel, Linnéa Bergenholm, Eman Ibrahim, Stergios Kechagias, Sara Hansson, Mathias Liljeblad, Patrik Nasr, Björn Carlsson, Mattias Ekstedt, Sebastian Ueckert Tags: ARTICLE Source Type: research

Physiologically Based Mechanistic Insight into Differential Risk of Valproate Hepatotoxicity between Children and Adults: A Focus on Ontogeny Impact
AbstractThe anticonvulsant valproic acid (VPA) despite complex pharmacokinetics has been in clinical use for nearly six decades. Previous reports indicated neonates, infants, and toddlers/preschoolers had higher risk of valproate hepatotoxicity than adults. However, dosing recommendations for those less than ten years of age are lacking. To decipher clinical puzzles, physiologically based pharmacokinetics (PBPK) models of VPA and its hepatotoxic metabolite 4-ene-VPA were constructed and simulated with particularly integrated information of drug-metabolizing enzyme ontogeny. Adult and pediatric PK data of VPA (n  = 143 ...
Source: CPT: Pharmacometrics and Systems Pharmacology - September 22, 2023 Category: Drugs & Pharmacology Authors: Yu ‐Ting Huang, Yen‐Ming Huang, Fan‐Lu Kung, Chun‐June Lin, Tun Jao, Yunn‐Fang Ho Tags: ARTICLE Source Type: research

Association between SARS ‐CoV‐2 viral kinetics and clinical score evolution in hospitalized patients
AbstractThe role of antiviral treatment in COVID-19 hospitalized patients is controversial. To address this question, we analyzed simultaneously nasopharyngeal viral load and the National Early Warning Score 2 (NEWS-2), using an effect compartment model to relate viral dynamics and the evolution of clinical severity. The model is applied to 664 hospitalized patients included in the DisCoVeRy trial (NCT04315948; EudraCT 2020-000936-23), randomized to either standard of care (SoC) or SoC + remdesivir. Then we use the model to simulate the impact of antiviral treatments on the time to clinical improvement, defined by a NEWS-2...
Source: CPT: Pharmacometrics and Systems Pharmacology - September 21, 2023 Category: Drugs & Pharmacology Authors: Nad ège Néant, Guillaume Lingas, Alexandre Gaymard, Drifa Belhadi, Maya Hites, Thérèse Staub, Richard Greil, Jose‐Artur Paiva, Julien Poissy, Nathan Peiffer‐Smadja, Dominique Costagliola, Yazdan Yazdanpanah, Maude Bouscambert‐Duchamp Tags: ARTICLE Source Type: research

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Source: CPT: Pharmacometrics and Systems Pharmacology - September 19, 2023 Category: Drugs & Pharmacology Tags: ISSUE INFORMATION Source Type: research

Population pharmacokinetics of apixaban in a real ‐life hospitalized population from the OptimAT study
This study aimed to characterize apixaban pharmacokinetics (PKs) and its variability in a real-world clinical setting of hospitalized patients using a population PK (PopPK) approach. Model-based simulations helped to identify factors that affect apixaban exposure and their clinical significance. A classic stepwise strategy was applied to determine the best PopPK model for describing typical apixaban PKs in hospitalized patients from the OptimAT study (n = 100) and evaluating the associated variability and influencing factors. Apixaban exposure under specific conditions was assessed using the final model. A two-compartm...
Source: CPT: Pharmacometrics and Systems Pharmacology - September 19, 2023 Category: Drugs & Pharmacology Authors: Fr édéric Gaspar, Jean Terrier, Samantha Favre, Pauline Gosselin, Pierre Fontana, Youssef Daali, Camille Lenoir, Caroline Flora Samer, Victoria Rollason, Jean‐Luc Reny, Chantal Csajka, Monia Guidi Tags: ARTICLE Source Type: research

Evaluation of the Effect of Erenumab on Migraine ‐Specific Questionnaire in Patients with Chronic and Episodic Migraine.
AbstractErenumab is a fully human anti-canonical calcitonin gene-related peptide receptor monoclonal antibody approved for migraine prevention. The Migraine-Specific Quality-of-Life Questionnaire (MSQ) is a 14-item patient-reported outcome instrument that measures the impact of migraine on health-related quality of life. Erenumab data from 4 phase 2/3 clinical trials were used to develop an Item Response Theory model within a non-linear mixed effects framework to (i) evaluate MSQ item information with respect to patient disability, (ii) characterize the longitidunal progression of MSQ, and (iii) quantify the effect of eren...
Source: CPT: Pharmacometrics and Systems Pharmacology - September 19, 2023 Category: Drugs & Pharmacology Authors: Po ‐Wei Chen, Mats O. Karlson, Sebastian Ueckert, Ari Pritchard‐Bell, Cheng‐Pang Hsu, Sandeep Dutta, Malidi Ahamadi Tags: ARTICLE Source Type: research