Results from a Validated in vitro Gastrointestinal Model (TIM) used as input Data for in silico Modeling Give Highly Predictive Information for the Human Situation

Results from a Validated in vitro Gastrointestinal Model (TIM) used as input Data for in silico Modeling Give Highly Predictive Information for the Human Situation

Authors: Havenaar R, Bellmann S
Publication: Medical Research Archives
Keywords: ACAT, gastroplus, in vitro dissolution, ivivr, pbbm, PBPK modeling, physiologically based biopharmaceutics
Software: GastroPlus®
Division: PBPK

The aim of this review paper is to evaluate the predictive quality of a combination of in vitro dynamic gastrointestinal models, mucosal transit models and in silico kinetic...

Translational Pharmacokinetics of a Novel Bispecific Antibody Against Ebola Virus (MBS77E) from Animal to Human by PBPK Modeling & Simulation

Translational Pharmacokinetics of a Novel Bispecific Antibody Against Ebola Virus (MBS77E) from Animal to Human by PBPK Modeling & Simulation

Authors: Zhang W, Xiang Y, Wang L, Wang F, Li G, Zhuang X
Publication: Int J Pharm
Keywords: antibodies, biologics, gastroplus, large molecules, monoclonal antibody, NAMVantage, PBPK modeling, physiologically based pharmacokinetics
Software: GastroPlus®
Therapeutic Areas: Biologics

The goal of this study was to construct a PBPK model to accelerate the translation of MBS77E, a humanized bispecific antibody against the Ebola virus.

Investigating the uncertainty of prediction accuracy for the application of physiologically based pharmacokinetic models to animal-free risk assessment of cosmetic ingredients

Investigating the uncertainty of prediction accuracy for the application of physiologically based pharmacokinetic models to animal-free risk assessment of cosmetic ingredients

Authors: Terasaka S, Hayashi A, Nukada Y, Yamane M
Publication: Regul Toxicol Pharmacol
Keywords: admet predictor, cosmetics, gastroplus, IVIVE, mechanistic absorption, ngra, PBPK modeling, physiologically based pharmacokinetics, safety research, toxiokinetics
Software: GastroPlus®

Physiologically based pharmacokinetic (PBPK) models are considered useful tools in animal-free risk assessment.

GastroPlus as an Educational Tool Teaching of Pharmacokinetics & Biopharmaceutics with PBPK Modeling

GastroPlus as an Educational Tool Teaching of Pharmacokinetics & Biopharmaceutics with PBPK Modeling

Authors: Morningstar-Kywi N, Haworth I, Nevarez J
Keywords: biopharmaceutics, educational software, gastroplus, PBPK modeling
Software: GastroPlus®
Division: PBPK

Students have an increased interest in learning physiologically based pharmacokinetic (PBPK) modeling, but this requires an in-depth understanding of biopharmaceutics and pharmacokinetics.

Gastrointestinal Fluid Volumes in Pediatrics: A Retrospective MRI Study

Gastrointestinal Fluid Volumes in Pediatrics: A Retrospective MRI Study

Authors: Van der Veken M, Aertsen M, Brouwers J, Stillhart C, Parrott N, Augustijns P
Publication: Pharmaceutics
Keywords: ACAT, biopharmaceutics, children, gastroplus, gut physiology, mechanistic absorption, pbbm, PBPK modeling, physiologically based pharmacokinetics
Software: GastroPlus®

The volume and distribution of fluids available in the gastrointestinal (GI) tract may substantially affect oral drug absorption.

A phase 1b dose escalation study of CD137 mAb agonist OC-001 as monotherapy in patients with advanced or metastatic cancer

A phase 1b dose escalation study of CD137 mAb agonist OC-001 as monotherapy in patients with advanced or metastatic cancer

Authors: Miller W, Provencher D, Chu Q, Jonker D, Batist G, Jamal R, Goel R, Hilton J, Spratlin J, Smith P, Darling IM, Zaknoen S, Stille JR, Fortier C, Mangat R
Conference: European Society for Medical Oncology (ESMO)
Keywords: advanced cancer, metastatic cancer, OC-001, PK, PK of OC-001, tolerability of OC-001
Division: Clinical Pharmacology and Pharmacometrics (CPP)

OC-001 is a CD137 mAb agonist designed to show differential agonistic activity from that of competitor
antibodies. OC-001 provided T cell activation that

Physiologically Based Pharmacokinetic (PBPK) Modeling of Pyrotinib to Understand the Impact of Interplay Between CYP3A4 and P-GP on its DDIs with CYP3A4 Inhibitors/Inducers

Physiologically Based Pharmacokinetic (PBPK) Modeling of Pyrotinib to Understand the Impact of Interplay Between CYP3A4 and P-GP on its DDIs with CYP3A4 Inhibitors/Inducers

Authors: Vora TB, Fraczkiewicz G, Zhao K, Li S, Shen K, Liu M, Djebli N, Sun S, Zhou M
Conference: ISSX
Keywords: CYP3A4, DDIs, gastroplus, in vivo, PBPK modeling
Software: ADMET Predictor®, GastroPlus®
Division: PBPK

To develop a PBPK model for pyrotinib and qualify it with the in vivo data obtained after oral administrations.

Implementation of a Physiologically Based Pharmacokinetic Modeling Approach to Predict Disease-Related Changes in Drug Pharmacokinetics in Patients with Nonalcoholic Fatty Liver Disease Conference name: International Society for the Study of Xenobiotics (ISSX)-Microsomes and Drug Oxidations (MDO) Joint Meeting

Implementation of a Physiologically Based Pharmacokinetic Modeling Approach to Predict Disease-Related Changes in Drug Pharmacokinetics in Patients with Nonalcoholic Fatty Liver Disease Conference name: International Society for the Study of Xenobiotics (ISSX)-Microsomes and Drug Oxidations (MDO) Joint Meeting

Authors: Adiwidjaja J, Spires J, Brouwer KL
Keywords: CYP2C8, NAFLD, NASH, OATP1B1, PBPK, pharmacokinetic
Software: GastroPlus®
Division: PBPK

Introduction: Understanding disease-related changes in the pharmacokinetics of drugs in patients with nonalcoholic fatty liver disease (NAFLD) is of clinical importance...

Utility of Physiologically Based Biopharmaceutics Modeling (PBBM) in Regulatory Perspective: Application to Supersede f2, Enabling Biowaivers & Creation of Dissolution Safe Space

Utility of Physiologically Based Biopharmaceutics Modeling (PBBM) in Regulatory Perspective: Application to Supersede f2, Enabling Biowaivers & Creation of Dissolution Safe Space

Authors: Bhattiprolu AK, Ahmed T, Boddu R, Chachad S
Publication: J Pharm Sci
Keywords: ACAT, bioequivalence, biopharmaceutics, biowaiver, gastroplus, mechanistic absorption, pbbm, PBPK modeling, physiologically based pharmacokinetics, vbe
Software: GastroPlus®
Therapeutic Areas: General/Other

Product DRL is a generic IR tablet formulation with BCS Class-III API, available in two strengths: 50mg & 100mg.

Project Optimus –FDA’s “New” Dose Optimization & Selection Paradigm in Oncology Drug Development

Project Optimus –FDA’s “New” Dose Optimization & Selection Paradigm in Oncology Drug Development

Authors: Booth BP, Zhu H, Sun T, Padron A
Keywords: Clinical Pharmacology & Pharmacometrics webinar, dose optimization, FDA guidance, Oncology Drug Development, project optimus
Division: Clinical Pharmacology and Pharmacometrics (CPP), PBPK

Dr. Brian P. Booth and Dr. Hao Zhu from the Office of Clinical Pharmacology (OCP) at the FDA will present and discuss Project Optimus, an initiative from the Oncology Center of Excellence (OCE) to reform the dose optimization and dose selection paradigm in oncology drug development.

Towards best use and regulatory acceptance of generic physiologically based kinetic (PBK) models for in vitro-to-in vivo extrapolation (IVIVE) in chemical risk assessment

Towards best use and regulatory acceptance of generic physiologically based kinetic (PBK) models for in vitro-to-in vivo extrapolation (IVIVE) in chemical risk assessment

Authors: Najjar A, Punt A, Wambaugh J, Paini A, Ellison C, Fragki S, Bianchi E, Zhang F, Westerhout J, Li H, Shi Q, Gant TW, Botham P, Bars R, Piersma A, van Ravenzwaay B, Kramer NI
Publication: Arch Toxicol
Keywords: admet predictor, gastroplus, IVIVE, mechanistic absorption, ngra, PBPK modeling, physiologically based pharmacokinetics, safety research, toxiokinetics
Software: GastroPlus®

With an increasing need to incorporate new approach methodologies (NAMs) in chemical risk assessment and the concomitant need to phase out animal testing, the interpretation of...

A novel transdermal ketoprofen formulation for analgesia in cattle

A novel transdermal ketoprofen formulation for analgesia in cattle

Authors: Mills PC, Owens JG, Reinbold JB, McGowan M, Ellenbergner C, Woldeyohannes S, Satake N
Publication: Journal of Veterinary Pharmacology and Therapeutics
Keywords: analgesia, animals, cattle, in vitro, ketoprofen, MonolixSuite Playlist, pkanalix, rspub, Transdermal delivery
Software: PKanalix®

Ketoprofen is registered in many countries for injectable administration in cattle.

Physiologically based Pharmacokinetic Models under the Prism of the Finite Absorption Time Concept

Physiologically based Pharmacokinetic Models under the Prism of the Finite Absorption Time Concept

Authors: Wu D, Tsekouras AA, Macheras P, Kesisoglou F
Publication: Pharmaceutical Research
Keywords: ACAT, biopharmaceutics, gastroplus, mechanistic absorption, pbbm, PBPK modeling, physiologically based pharmacokinetics
Software: GastroPlus®

To date, mechanistic modeling of oral drug absorption has been achieved via the use of physiologically based pharmacokinetic (PBPK) modeling, and more specifically, physiologically...