PBPK Modeling and Simulation and Therapeutic Drug Monitoring: Possible Ways for Antibiotic Dose Adjustment

PBPK Modeling and Simulation and Therapeutic Drug Monitoring: Possible Ways for Antibiotic Dose Adjustment

Authors: Ferreira A, Lapa R, Vale N
Publication: Processes
Keywords: biopharmaceutics, dose selection, gastroplus, mechanistic absorption model, pbbm, PBPK modeling, pediatrics, virtual populations
Software: GastroPlus®
Division: PBPK

Pharmacokinetics (PK) is a branch of pharmacology present and of vital importance for the research and development (R&D) of new drugs, post-market monitoring, and continued optimizations in clinical contexts.

Application of PBPK modeling & simulation to support dose selection in special populations – Bilastine as a case example

Application of PBPK modeling & simulation to support dose selection in special populations – Bilastine as a case example

Authors: Vozmediano V, Kim C, Nevarez J, O’Connor D
Keywords: dose selection, gastroplus, PBPK modeling, population modeling & simulation, University of Florida, University+, University+ Program
Software: GastroPlus®
Division: PBPK

Dose recommendations are usually established using data driven approaches, i.e., population modeling & simulation...

Quantitative Systems Pharmacology (QSP) Model Predicts Lack of Efficacy for Cenicriviroc, a CCR2/5 Antagonist, in NAFLD/NASH Patients

Quantitative Systems Pharmacology (QSP) Model Predicts Lack of Efficacy for Cenicriviroc, a CCR2/5 Antagonist, in NAFLD/NASH Patients

Authors: Battista C, Shoda LKM, Generaux GT, Siler SQ
Conference: AASLD
Keywords: CCR2/5, cenicriviroc (CVC), in vitro, in vivo, NAFLDsym, nonalcoholic steatohepatitis (NASH), PBPK, quantitative systems pharmacology (QSP)
Software: NAFLDsym®
Division: Quantitative Systems Pharmacology (QSP)

A phase 3 clinical trial (AURORA) for cenicriviroc (CVC), a CC chemokine receptor 2 and 5 (CCR2/5) antagonist, was recently...

Advancing Calcitonin Gene-Related Peptide Receptor Antagonists Using Quantitative Systems Toxicology Modeling to Characterize Next-in-Class Compounds Compared to the Hepatotoxic First in Class Telcagepant

Advancing Calcitonin Gene-Related Peptide Receptor Antagonists Using Quantitative Systems Toxicology Modeling to Characterize Next-in-Class Compounds Compared to the Hepatotoxic First in Class Telcagepant

Authors: Woodhead JL, Siler SQ, Howell BA, Conway C, Watkins PB
Conference: AASLD
Keywords: hepatoxicity, QST modeling, quantitative systems toxicology (QST) analysis, telcagepant
Software: DILIsym®
Division: Quantitative Systems Pharmacology (QSP)

While CGRP receptor antagonists have demonstrated efficacy in the acute and preventive treatment of migraine...

Physiologically Based Pharmacokinetic Modeling and Dose Adjustment of Teicoplanin in Pediatric Patients With Renal Impairment

Physiologically Based Pharmacokinetic Modeling and Dose Adjustment of Teicoplanin in Pediatric Patients With Renal Impairment

Authors: Xu J, Lin R, Chen Y, You X, Huang P, Lin C
Publication: J Clin Pharmacol
Keywords: Chinese, disease state, dose optimization, dose selection, gastroplus, PBPK modeling, pediatrics, physiologically based pharmacokinetics, renal impairment
Software: GastroPlus®

The pharmacokinetics of teicoplanin differs in children as compared with adults, and especially in renally impaired pediatric patients.

Suppressing TGF-β activation to reduce lung fibrosis: In search for an efficacious dose regimen for alpha V integrin inhibitors

Suppressing TGF-β activation to reduce lung fibrosis: In search for an efficacious dose regimen for alpha V integrin inhibitors

Authors: Ermakov S, Generaux GT, Singh FA, Chandra A, Siler SQ
Conference: ACoP
Keywords: idiopathic pulmonary fibrosis, lung fibrosis, pulmonary playlist, QSP modeling
Software: IPFsym®
Division: Quantitative Systems Pharmacology (QSP)

Elevated levels of TGF-β and specifically its activated form is regarded as one of the disease drivers in patients with idiopathic pulmonary fibrosis (IPF).

Population Pharmacokinetics Analysis for Molnupiravir in Adults with COVID-19

Population Pharmacokinetics Analysis for Molnupiravir in Adults with COVID-19

Authors: Gao W, Bihorel S, Humphrey RL, Cao Y, Chawla A, Birger R, Sardella S, Kondragunta S, Jayaraman B, Painter W, Holman W, Stone J
Conference: ACoP
Keywords: COVID-19, PK analysis, SARS-CoV-2
Division: Clinical Pharmacology and Pharmacometrics (CPP)

There is an urgent need for safe and effective oral treatments for COVID-19 that reduce progression to severe illness and risk of hospitalization or death

CARDIOsym QSP model prediction of wound healing response following myocardial infarction

CARDIOsym QSP model prediction of wound healing response following myocardial infarction

Authors: Kenz Z, Battista C, Shoda LKM, Gebremichael Y, Siler SQ, Powell L, Cheng L
Conference: ACoP
Keywords: biphasic, CARDIOsym, fibrosis, inflammation, myocardial infarction, pathophysiology, quantitative systems pharmacology (QSP), response, therapeutics, wound healing
Software: CARDIOsym
Division: Quantitative Systems Pharmacology (QSP)

Objectives: Cardiac wound healing post-myocardial infarction represents a complex balance between inflammation and fibrosis (Richardson 2017). A biphasic...

Optimized In Silico Modeling of Drug Absorption after Gastric Bypass: The Case of Metformin

Optimized In Silico Modeling of Drug Absorption after Gastric Bypass: The Case of Metformin

Authors: Dahan A, Porat D, Markovic M, Zur M, Kister O, Langguth P
Publication: Pharmaceutics
Keywords: bariatric surgery, formulation design, gastroplus, mechanistic absorption model, pbbm, PBPK modeling, physiologically based biopharmaceutics, special population
Software: GastroPlus®

Bariatric surgery is an effective treatment for severe obesity and related comorbidities, such as type II diabetes. Gastric bypass surgery shortens the length of the intestine, possibly leading to altered drug absorption.