Nikunjkumar Patel
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View article: Assessing Cytochrome <scp>P450</scp> Drug Interaction Risk for Dordaviprone Using Physiologically Based Pharmacokinetic Modeling
Assessing Cytochrome <span>P450</span> Drug Interaction Risk for Dordaviprone Using Physiologically Based Pharmacokinetic Modeling Open
A physiologically based pharmacokinetic (PBPK) model was developed and verified for dordaviprone, a small molecule with antitumor effects in glioma patients. The model was applied to assess the drug–drug interaction (DDI) potential of dord…
View article: Advances in Physiologically Based Pharmacokinetic (PBPK) Modeling and its Regulatory Utility to Support Oral Drug Product Development and Harmonization
Advances in Physiologically Based Pharmacokinetic (PBPK) Modeling and its Regulatory Utility to Support Oral Drug Product Development and Harmonization Open
This report summarizes the proceedings of Session 1 of the one-day public workshop titled “ Advances in PBPK Modeling and its Regulatory Utility for Oral Drug Product Development ” hosted by the U.S. Food and Drug Administration (FDA) and …
View article: PBPK Modeling to Support Bioavailability and Bioequivalence Assessment in Pediatric Populations
PBPK Modeling to Support Bioavailability and Bioequivalence Assessment in Pediatric Populations Open
This report summarizes the proceedings for Session 3 of the one-day public workshop entitled “Advances in PBPK Modeling and its Regulatory Utility for Oral Drug Product Development” a jointly sponsored workshop by U.S. Food and Drug Admini…
View article: PBBM Considerations for Base Models, Model Validation, and Application Steps: Workshop Summary Report
PBBM Considerations for Base Models, Model Validation, and Application Steps: Workshop Summary Report Open
The proceedings from the 30th August 2023 (Day 2) of the workshop "Physiologically Based Biopharmaceutics Models (PBBM) Best Practices for Drug Product Quality: Regulatory and Industry Perspectives" are provided herein. Day 2 covered PBBM …
View article: Physiologically‐based pharmacokinetic model of sparsentan to evaluate drug–drug interaction potential
Physiologically‐based pharmacokinetic model of sparsentan to evaluate drug–drug interaction potential Open
Sparsentan is a dual endothelin/angiotensin II receptor antagonist indicated to reduce proteinuria in patients with primary IgA nephropathy at high risk of disease progression. In vitro data indicate that sparsentan is likely to inhibit or…
View article: Physiologically Based Pharmacokinetic Model Development and Verification for Bioequivalence Testing of Bempedoic Acid Oral Suspension and Reference Tablet Formulation
Physiologically Based Pharmacokinetic Model Development and Verification for Bioequivalence Testing of Bempedoic Acid Oral Suspension and Reference Tablet Formulation Open
The bioequivalence of bempedoic acid oral suspension and commercial immediate release (IR) tablet formulations were assessed using a physiologically based pharmacokinetic (PBPK) model. The mechanistic model, developed from clinical mass ba…
View article: PMON116 Central Diabetes Insipidus in a patient with Pituitary Macroadenoma status post Trans-sphenoidal Resection, complicated by Nephrogenic Diabetes Insipidus due to Chronic Lithium use
PMON116 Central Diabetes Insipidus in a patient with Pituitary Macroadenoma status post Trans-sphenoidal Resection, complicated by Nephrogenic Diabetes Insipidus due to Chronic Lithium use Open
59-year-old female with PMH of Bipolar disorder and Pituitary macroadenoma presented to the ER yesterday for worsening Headache associated with nausea, vomiting and double vision. Detailed imaging of the pituitary gland demonstrated a hypo…
View article: Multi‐phase multi‐layer mechanistic dermal absorption (MPML MechDermA) model to predict local and systemic exposure of drug products applied on skin
Multi‐phase multi‐layer mechanistic dermal absorption (MPML MechDermA) model to predict local and systemic exposure of drug products applied on skin Open
Physiologically‐based pharmacokinetic models combine knowledge about physiology, drug product properties, such as physicochemical parameters, absorption, distribution, metabolism, excretion characteristics, formulation attributes, and tria…
View article: Collaborative Robotic Environment for Educational Training in Industry 5.0 Using an Open Lab Approach
Collaborative Robotic Environment for Educational Training in Industry 5.0 Using an Open Lab Approach Open
This paper focuses on the laboratory setup that enables modern education concepts related to collaborative robotics. This facility is meant to be an open lab environment where the access is free and all the necessary resources are availabl…
View article: Proof of Concept in Assignment of Within-Subject Variability During Virtual Bioequivalence Studies: Propagation of Intra-Subject Variation in Gastrointestinal Physiology Using Physiologically Based Pharmacokinetic Modeling
Proof of Concept in Assignment of Within-Subject Variability During Virtual Bioequivalence Studies: Propagation of Intra-Subject Variation in Gastrointestinal Physiology Using Physiologically Based Pharmacokinetic Modeling Open
While the concept of ‘Virtual Bioequivalence’ (VBE) using a combination of modelling, in vitro tests and integration of pre-existing data on systems and drugs is growing from its infancy, building confidence on VBE outcomes requires demons…
View article: Retrospective analysis of anti-inflammatory therapies during the first wave of COVID-19 at a community hospital
Retrospective analysis of anti-inflammatory therapies during the first wave of COVID-19 at a community hospital Open
BACKGROUND: Our understanding of the severe acute respiratory syndrome coronavirus 2 has evolved since the first reported cases in December 2019, and a greater emphasis has been placed on the hyper-inflammatory response in severely ill pat…
View article: Packed Red Blood Cell Transfusion as a Potential Treatment Option in COVID-19 Patients With Hypoxemic Respiratory Failure: A Case Report
Packed Red Blood Cell Transfusion as a Potential Treatment Option in COVID-19 Patients With Hypoxemic Respiratory Failure: A Case Report Open
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is the cause of coronavirus disease 2019 (COVID-19), an ongoing pandemic that started as an outbreak in China. The clinical picture varies from asymptomatic or mild cases to crit…
View article: Virtual Thorough QT (TQT) Trial—Extrapolation of In Vitro Cardiac Safety Data to In Vivo Situation Using Multi-Scale Physiologically Based Ventricular Cell-wall Model Exemplified with Tolterodine and Fesoterodine
Virtual Thorough QT (TQT) Trial—Extrapolation of In Vitro Cardiac Safety Data to In Vivo Situation Using Multi-Scale Physiologically Based Ventricular Cell-wall Model Exemplified with Tolterodine and Fesoterodine Open
View article: Towards Bridging Translational Gap in Cardiotoxicity Prediction: an Application of Progressive Cardiac Risk Assessment Strategy in TdP Risk Assessment of Moxifloxacin
Towards Bridging Translational Gap in Cardiotoxicity Prediction: an Application of Progressive Cardiac Risk Assessment Strategy in TdP Risk Assessment of Moxifloxacin Open
View article: Quantitative approach for cardiac risk assessment and interpretation in tuberculosis drug development
Quantitative approach for cardiac risk assessment and interpretation in tuberculosis drug development Open
View article: Real Patient and its Virtual Twin: Application of Quantitative Systems Toxicology Modelling in the Cardiac Safety Assessment of Citalopram
Real Patient and its Virtual Twin: Application of Quantitative Systems Toxicology Modelling in the Cardiac Safety Assessment of Citalopram Open
View article: Model-Based Analysis of Biopharmaceutic Experiments To Improve Mechanistic Oral Absorption Modeling: An Integrated <i>in Vitro in Vivo</i> Extrapolation Perspective Using Ketoconazole as a Model Drug
Model-Based Analysis of Biopharmaceutic Experiments To Improve Mechanistic Oral Absorption Modeling: An Integrated <i>in Vitro in Vivo</i> Extrapolation Perspective Using Ketoconazole as a Model Drug Open
Mechanistic modeling of in vitro data generated from metabolic enzyme systems (viz., liver microsomes, hepatocytes, rCYP enzymes, etc.) facilitates in vitro-in vivo extrapolation (IVIV_E) of metabolic clearance which plays a key role in th…
View article: Virtual bioequivalence for achlorhydric subjects: The use of PBPK modelling to assess the formulation-dependent effect of achlorhydria
Virtual bioequivalence for achlorhydric subjects: The use of PBPK modelling to assess the formulation-dependent effect of achlorhydria Open
View article: Early assessment of proarrhythmic risk of drugs using the <i>in vitro</i> data and single-cell-based <i>in silico</i> models: proof of concept
Early assessment of proarrhythmic risk of drugs using the <i>in vitro</i> data and single-cell-based <i>in silico</i> models: proof of concept Open
Background and purpose: To determine the predictive performance of in silico models using drug-specific preclinical cardiac electrophysiology data to investigate drug-induced arrhythmia risk (e.g. Torsade de pointes (TdP)) in…
View article: Early assessment of proarrhythmic risk of drugs using the <i>in vitro</i> data and single-cell-based <i>in silico</i> models: proof of concept
Early assessment of proarrhythmic risk of drugs using the <i>in vitro</i> data and single-cell-based <i>in silico</i> models: proof of concept Open
We reproduced the underlying biophysical characteristics of cardiac cells resulted in effects of drugs associated with cardiac arrhythmias (action potential duration (APD) and QT prolongation and TdP) which were observed in published 3D si…
View article: Does size matter? Kidney transplant donor size determines kidney function among living donors
Does size matter? Kidney transplant donor size determines kidney function among living donors Open
Larger kidney donors were more likely to achieve an eGFR ≥60 mL/min/1.73 m2 with renal recovery over a shorter duration due to higher pre-donation and initial post-nephrectomy eGFRs.
View article: Comment on “<i>In Silico</i> Modeling of Gastrointestinal Drug Absorption: Predictive Performance of Three Physiologically-Based Absorption Models”
Comment on “<i>In Silico</i> Modeling of Gastrointestinal Drug Absorption: Predictive Performance of Three Physiologically-Based Absorption Models” Open
ADVERTISEMENT RETURN TO ISSUEPREVCommunicationNEXTComment on "In Silico Modeling of Gastrointestinal Drug Absorption: Predictive Performance of Three Physiologically-Based Absorption Models"David B. Turner*†, Bo Liu†, Nikunjkumar Patel†, S…
View article: Data Mining: Privacy Preservation in Data Mining Using Perturbation Techniques
Data Mining: Privacy Preservation in Data Mining Using Perturbation Techniques Open
Approved and recommended for acceptance as a project in partial fulfillment of the requirements for the degree of Master of Science in Computer and Information Sciences.
View article: Psoriasis induced toxic shock-like syndrome mimicking hemolytic uremic syndrome
Psoriasis induced toxic shock-like syndrome mimicking hemolytic uremic syndrome Open
International Journal of Case Reports and Images (IJCRI)International Journal of Case Reports and Images (IJCRI) is an international, peer reviewed, monthly, open access, online journal, publishing high-quality, articles in all areas of ba…