CPT: Pharmacometrics and Systems Pharmacology 
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This is an RSS file. You can use it to subscribe to this data in your favourite RSS reader or to display this data on your own website or blog.Applied physiologically ‐based pharmacokinetic modeling to assess uridine diphosphate‐glucuronosyltransferase‐mediated drug–drug interactions for Vericiguat
This study is a first cornerstone to qualify the PK- Sim platform for use of UGT-mediated DDI predictions, including PBPK models of perpetrators, such as mefenamic acid and atazanavir, and sensitive UGT substrates, such as dapagliflozin and raltegravir. (Source: CPT: Pharmacometrics and Systems Pharmacology)
Source: CPT: Pharmacometrics and Systems Pharmacology - October 12, 2023 Category: Drugs & Pharmacology Authors: Sebastian Frechen,
Ibrahim Ince,
Andr é Dallmann,
Michael Gerisch,
Natalia A. Jungmann,
Corina Becker,
Maximilian Lobmeyer,
Maria E. Trujillo,
Shiyao Xu,
Rolf Burghaus,
Michaela Meyer Tags: ARTICLE Source Type: research
A multicompartment population PK model to predict tenofovir and emtricitabine mucosal tissue concentrations for HIV prevention
AbstractA priori use of mathematical modeling and simulation to predict outcomes from incomplete adherence or reduced frequency dosing strategies may mitigate the risk of clinical trial failure with HIV pre-exposure prophylaxis regimens. We developed a semi-physiologic population pharmacokinetic model for two antiretrovirals and their active intracellular metabolites in three mucosal tissues using pharmacokinetic data from a phase I, dose-ranging study. Healthy female volunteers were given a single oral dose of tenofovir disoproxil fumarate (150, 300, or 600 mg) or emtricitabine (100, 200, or 400 mg). Simultaneous co-...
Source: CPT: Pharmacometrics and Systems Pharmacology - October 10, 2023 Category: Drugs & Pharmacology Authors: Erick Leung,
Mackenzie L. Cottrell,
Craig Sykes,
Nicole White,
Angela D. M. Kashuba,
Julie B. Dumond Tags: ARTICLE Source Type: research
Dosing recommendation of nirmatrelvir/ritonavir using an integrated population pharmacokinetic analysis
AbstractProtease inhibitor nirmatrelvir coadministered with ritonavir as a pharmacokinetic enhancer (PAXLOVID ™; Pfizer Inc) became the first orally bioavailable antiviral agent granted Emergency Use Authorization in the United States in patients ≥12 years old with mild to moderate coronavirus disease 2019 (COVID-19). This population pharmacokinetic analysis used pooled plasma nirmatrelvir concentrati ons from eight completed phase I and II/III studies to characterize nirmatrelvir pharmacokinetics when coadministered with ritonavir in adults with/without COVID-19. Influence of covariates (e.g., formulation, dose, COV...
Source: CPT: Pharmacometrics and Systems Pharmacology - October 8, 2023 Category: Drugs & Pharmacology Authors: Phylinda L. S. Chan,
Ravi Shankar P. Singh,
Donna S. Cox,
Haihong Shi,
Bharat Damle,
Timothy Nicholas Tags: ARTICLE Source Type: research
Population pharmacokinetics of molnupiravir in adults with COVID ‐19: Lack of clinically important exposure variation across individuals
AbstractEffective antiviral treatments for coronavirus disease 2019 (COVID-19) are needed to reduce the morbidity and mortality associated with severe acute respiratory syndrome-coronavirus 2 (SARS-CoV-2) infection, particularly in patients with risk factors for severe disease. Molnupiravir (MK-4482, EIDD-2801) is an orally administered, ribonucleoside prodrug of β-D-N4-hydroxycytidine (NHC) with submicromolar potency against SARS-CoV-2. A population pharmacokinetic (PopPK) analysis for molnupiravir exposure was conducted using 4202 NHC plasma concentrations collected in 1207 individuals from a phase I trial in healthy pa...
Source: CPT: Pharmacometrics and Systems Pharmacology - October 6, 2023 Category: Drugs & Pharmacology Authors: S ébastien Bihorel,
Youfang Cao,
Akshita Chawla,
Ruthie Birger,
Brian M. Maas,
Wei Gao,
Stefan Roepcke,
Susanne Sardella,
Rebecca Humphrey,
Sindhuri Kondragunta,
Bhuvana Jayaraman,
Monika Martinho,
Wendy Painter,
George Painter,
Wayne Holma Tags: ARTICLE Source Type: research
Physiologically ‐based pharmacokinetic model to predict doxorubicin and paclitaxel exposure in infants through breast milk
AbstractLimited information is available concerning infant exposure and safety when breastfed by mothers receiving chemotherapy. Whereas defining distribution to breast milk is important to infer drug exposure, infant pharmacokinetics also determine to what extent the infant will be exposed to potential toxic effects. We aimed to assess the impact of chemotherapy containing breast milk on infants by predicting systemic and local (intestinal) exposure of paclitaxel and doxorubicin in infants through breast milk using a physiologically-based pharmacokinetic (PBPK) approach. Whole-body PBPK models of i.v. paclitaxel and doxor...
Source: CPT: Pharmacometrics and Systems Pharmacology - October 6, 2023 Category: Drugs & Pharmacology Authors: David Damoiseaux,
Fr édéric Amant,
Jos H. Beijnen,
Shelby Barnett,
Gareth J. Veal,
Alwin D. R. Huitema,
Thomas P. C. Dorlo Tags: ARTICLE Source Type: research
Applied Physiologically Based Pharmacokinetic Modeling to assess UGT ‐mediated Drug–Drug Interactions for Vericiguat
This study is a first cornerstone to qualify the PK-Sim® pla tform for use of UGT-mediated DDI predictions including PBPK models of perpetrators such as mefenamic acid and atazanavir, and sensitive UGT substrates such as dapagliflozin and raltegravir. (Source: CPT: Pharmacometrics and Systems Pharmacology)
Source: CPT: Pharmacometrics and Systems Pharmacology - October 5, 2023 Category: Drugs & Pharmacology Authors: Sebastian Frechen,
Ibrahim Ince,
Andr é Dallmann,
Michael Gerisch,
Natalia A. Jungmann,
Corina Becker,
Maximilian Lobmeyer,
Maria E. Trujillo,
Shiyao Xu,
Rolf Burghaus,
Michaela Meyer Tags: ARTICLE Source Type: research
Apixaban and rivaroxaban's physiologically ‐based pharmacokinetic model validation in hospitalized patients: A first step for larger use of a priori modeling approach at bed side
AbstractWhen used in real-world conditions, substantial interindividual variations in direct oral anticoagulant (DOAC) plasma concentrations are observed for a given dose, leading to a risk of over- or under-exposure and clinically significant adverse events. Physiologically-based pharmacokinetic (PBPK) models could help physicians to tailor DOAC prescriptions in vulnerable patient populations, such as those in the hospital setting. The present study aims to validate prospectively PBPK models for rivaroxaban and apixaban in a large cohort of elderly, polymorbid, and hospitalized patients. In using a model of geriatric popu...
Source: CPT: Pharmacometrics and Systems Pharmacology - October 5, 2023 Category: Drugs & Pharmacology Authors: Jean Terrier,
Fr édéric Gaspar,
Pauline Gosselin,
Olivier Raboud,
Camille Lenoir,
Victoria Rollason,
Chantal Csajka,
Caroline Samer,
Pierre Fontana,
Youssef Daali,
Jean‐Luc Reny,
for the OptimAT study group Tags: ARTICLE Source Type: research
