The bioequivalence study design recommendations for immediate-release solid oral dosage forms in the international pharmaceutical regulators programme participating regulators and organisations: differences and commonalities

The bioequivalence study design recommendations for immediate-release solid oral dosage forms in the international pharmaceutical regulators programme participating regulators and organisations: differences and commonalities

Authors: Freitas Fernandes EA, Van Oudtshoorn J, Tam A, Gonzalez LCA, Aurela EG, Potthast H, Mettke K, Kuribayashi R, Shimojo K, Kasuga M, Morales L, Rodriguez Z, Jones B, Ahn C, Yun E, Kim SH, Rodrigues C, Tiong T, Crane C, Walther C, Roost MS, Chen TL, Hsu LF, Braddy A, Garcia-Arieta A, Abalos I, Divinsky M, Alsuwyeh A, Alzenaidy B, Alharf A
Publication: Journal of Pharmacy & Pharmaceutical Sciences
Keywords: bioequivalence, ICH, immediate release, IPRP, study design

Bioequivalence (BE) studies are considered the standard for demonstrating that the performance of a generic drug product in the human body is sufficiently similar to that of its comparator product.

QSP in the Real World: Where Has Quantitative Systems Pharmacology (QSP) Been Used to Support Drug Development and With What Impact?
  • Blog

QSP in the Real World: Where Has Quantitative Systems Pharmacology (QSP) Been Used to Support Drug Development and With What Impact?

Authors: Shoda L
Keywords: carcinogenic hazard, dosing regimens, Phase 1, PK and nonclinical data, QSP model, quantitative systems pharmacology (QSP)
Division: Quantitative Systems Pharmacology (QSP)

Quantitative systems pharmacology (QSP) is gaining acceptance and utilization in many drug development programs, but even those who appreciate its value may not fully recognize the extent to which it has already achieved impact and/or its range of potential applications.

Evaluating Immune Checkpoint Inhibitors for Liver Toxicity in a Biomimetic Liver Microphysiology Model

Evaluating Immune Checkpoint Inhibitors for Liver Toxicity in a Biomimetic Liver Microphysiology Model

Authors: Huizar F, Vernetti L, Clemens L, Beaudoin J, Siler SQ, Shoda LKM, Miedel MT, Castiglione M, Howell BA, Yang K, Taylor DL
Conference: SOT
Keywords: BILI, BIOLOGXsym, biomimetic, immune checkpoint inhibitors, liver toxicity
Software: BIOLOGXsym
Division: Quantitative Systems Pharmacology (QSP)

The prominence of biologic drugs has rapidly gained traction and has delivered life-changing...

Investigating the Potential Hepatotoxicity of ORM-48824 in a Quantitative Systems Toxicology Platform for Liver Safety, DILIsym®

Investigating the Potential Hepatotoxicity of ORM-48824 in a Quantitative Systems Toxicology Platform for Liver Safety, DILIsym®

Authors: Bhargava P, Tallapaka SB, Korjamo T, Howell BA, Malinen M, Oinonen T
Conference: SOT
Keywords: DILIsym, hepatoxicity, liver safety, MITOsym, QST, Quantitative Systems Toxicology (QST)
Software: DILIsym®, MITOsym®
Division: Quantitative Systems Pharmacology (QSP)

ORM-48824 is a transient receptor potential Ankyrin-1 (TRPA1) antagonist and was initially being developed for patients with diabetic neuropathic pain...

Prediction of Multidrug Resistance Protein 3 (MDR3) Inhibition-mediated Cholestatic Drug-induced Liver Injury (DILI) Using Quantitative Systems Toxicology (QST) Modeling

Prediction of Multidrug Resistance Protein 3 (MDR3) Inhibition-mediated Cholestatic Drug-induced Liver Injury (DILI) Using Quantitative Systems Toxicology (QST) Modeling

Authors: Beaudoin J, Adiwidjaja J, Yang K, Woodhead JL
Conference: SOT
Keywords: DILIsym, drug induced liver injury (DILI), modeling, multidrug resistance protein 3 (MDR3), Quantitative Systems Toxicology (QST)
Software: DILIsym®
Division: Quantitative Systems Pharmacology (QSP)

DILI is a primary cause of acute liver failure and reason for the termination of drug development programs...

Modeling and Simulation of Acetaminophen Pharmacokinetics and Hepatic Biomarkers After Overdoses of Extended-Release and Immediate-Release Formulations with DILIsym, a Quantitative Systems Toxicology (QST) Software Platform

Modeling and Simulation of Acetaminophen Pharmacokinetics and Hepatic Biomarkers After Overdoses of Extended-Release and Immediate-Release Formulations with DILIsym, a Quantitative Systems Toxicology (QST) Software Platform

Authors: Howell BA, Yang K, Beaudoin J, Lakhani VV, Woodhead JL, Lai JCK, Gelotte CK, Atillasoy E, Sista S
Conference: SOT
Keywords: acetaminophen, DILIsym, hepatic biomarker, modeling and simulation, overdose, pharmacokinetics, QST, Quantitative Systems Toxicology (QST)
Software: DILIsym®, GastroPlus®
Division: Quantitative Systems Pharmacology (QSP)

The analgesic/antipyretic acetaminophen (APAP) has multiple formulations including immediate-, modified-, and extended-release preparations...

A Novel Stability-Indicating RP-HPLC Method for the Simultaneous Estimation and In Vitro and In vivo Evaluation: Curcumin and Naringin Co-amorphous System

A Novel Stability-Indicating RP-HPLC Method for the Simultaneous Estimation and In Vitro and In vivo Evaluation: Curcumin and Naringin Co-amorphous System

Authors: Mallya P, Yarlagadda DL, Lewis S
Publication: Food Anal Methods
Keywords: compartmental pharmacokinetics, gastroplus, nca, non-compartmental pharmacokinetics
Software: GastroPlus®

Curcumin (CUR) is a phytochemical widely used in food industries, cosmetics, and in the treatment of various ailments. It is a polyphenol derived from turmeric and is often considered the golden spice.

Screening inhibitors against the Ef-Tu of Fusobacterium nucleatum: a docking, ADMET and PBPK assessment study

Screening inhibitors against the Ef-Tu of Fusobacterium nucleatum: a docking, ADMET and PBPK assessment study

Authors: Alzamami A, Alturki NA, Khan K, Basharat Z, Mashraqi MM
Publication: Mol Divers
Keywords: gastroplus, high throughput pharmacokinetics, lead selection, library screening, machine learning, PBPK modeling, physiologically based pharmacokinetics
Software: GastroPlus®

The oral pathogen Fusobacterium nucleatum has recently been associated with an elevated risk of colorectal cancer (CRC), endometrial metastasis, chemoresistance, inflammation, metastasis, and DNA damage, along with several other diseases.

Prediction of Human Pharmacokinetics of E0703, a Novel Radioprotective Agent, Using Physiologically Based Pharmacokinetic Modeling and an Interspecies Extrapolation Approach

Prediction of Human Pharmacokinetics of E0703, a Novel Radioprotective Agent, Using Physiologically Based Pharmacokinetic Modeling and an Interspecies Extrapolation Approach

Authors: Ge YX, Zhang Z, Yan JY, Ma ZC, Wang YG, Xiao CR, Zhuang XM, Gao Y
Publication: Int J Mol Sciences
Keywords: animal scaling, dose selection, fih, first-in-human, gastroplus, in vitro–in vivo extrapolation, IVIVE, PBPK modeling, physiologically based pharmacokinetics, translational science
Software: GastroPlus®

E0703, a new steroidal compound optimized from estradiol, significantly increased cell proliferation and the survival rate of KM mice and beagles after ionizing radiation.