Current Practices, Gap Analysis and Proposed Workflows for PBPK Modeling of Cytochrome P450 Induction: An Industry Perspective

Current Practices, Gap Analysis and Proposed Workflows for PBPK Modeling of Cytochrome P450 Induction: An Industry Perspective

Authors: Hariparsad N, Ramsden D, Taskar K, Badée J, Venkatakrishnan K, Reddy MB, Cabalu T, Mukherjee D, Rehmel J, Bolleddula J, Emami Riedmaier A, Prakash C, Chanteux H, Mao J, Umehara K, Shah K, De Zwart L, Dowty M, Kotsuma M, Li M, Pilla Reddy V, McGinnity DF, Parrott N
Publication: Pharmacol Ther
Keywords: CYP Enzymes, ddI, Drug-drug interactions, gastroplus, metabolic induction, PBPK modeling, physiologically based pharmacokinetics
Software: GastroPlus®

The International Consortium for Innovation and Quality (IQ) Physiologically Based Pharmacokinetic modeling (PBPK) Induction Working Group (IWG) conducted a survey across participating companies around general strategies for PBPK modeling of...

Simulations Plus Extends its Distributor Agreement in Japan with Northern Science Consulting for Monolix™

Simulations Plus Extends its Distributor Agreement in Japan with Northern Science Consulting for Monolix™

Keywords: consulting, Goh Murakami, Japan, Japanese pharmaceutical industry, MonolixSuite, MonolixSuite Playlist, Northern Science Consulting
Software: ADMET Predictor®, GastroPlus®, Monolix®
Division: Clinical Pharmacology and Pharmacometrics (CPP), PBPK

Complementing the existing distributorship with ADMET Predictor® and GastroPlus® software

Stimuli to the Revision Process: The Case for Apex Vessels Stimuli articles do not necessarily reflect the policies of the USPC or the USP Council of Experts

Stimuli to the Revision Process: The Case for Apex Vessels Stimuli articles do not necessarily reflect the policies of the USPC or the USP Council of Experts

Authors: Mann J, Cohen M, Abend A, Coutant C, Ashworth L, Shaw R
Publication: Dissolut Technol
Keywords: biopharmaceutics, dissolution, gastroplus, in vitro, mechanistic absorption model, pbbm, PBPK modeling
Software: GastroPlus®

Apex vessels (previously known as PEAK vessels) are an important element of the dissoluton scientst's toolbox and are frequently used in pharmaceutcal drug product development setngs

Validation of non-compartmental analysis (NCA) and bioequivalence results of PKanalix with respect to Phoenix WinNonLin

Validation of non-compartmental analysis (NCA) and bioequivalence results of PKanalix with respect to Phoenix WinNonLin

Authors: Pasquiers B, Gualano V, Twarogowska M, Ayral G
Keywords: bioequivalence, compartmental analysis (CA), drug-drug interactions (DDIs), Food effects, MonolixSuite Playlist, noncompartmental analysis (NCA), pharmacokinetics, pkanalix feature
Software: Monolix®, PKanalix®
Division: Clinical Pharmacology and Pharmacometrics (CPP)

Non-compartmental analysis (NCA) is used at all stages of drug development and is a key method to understand the pharmacokinetic properties of a compound.

Development of a lower-sodium oxybate formulation for the treatment of patients with narcolepsy and idiopathic hypersomnia

Development of a lower-sodium oxybate formulation for the treatment of patients with narcolepsy and idiopathic hypersomnia

Authors: Junnarkar G, Allphin C, Profant J, Steininger TL, Chen C, Zomorodi K, Skowronski R, Black J
Publication: Expert Opin Drug Discov
Keywords: formulation design, gastroplus, mechanistic absorption model, pbbm, PBPK modeling, physiologically based biopharmaceutics, salt selection, virtual populations
Software: GastroPlus®

Sodium oxybate (SXB) is a standard of care for cataplexy, excessive daytime sleepiness, and disrupted nighttime sleep in narcolepsy.

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.