Publications by authors named "Nikunjkumar Patel"

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Assessing Cytochrome P450 Drug Interaction Risk for Dordaviprone Using Physiologically Based Pharmacokinetic Modeling.
Swati Jaiswal, Nikunjkumar K Patel, Hannah M Jones, Savannah McFeely, Shamia L Faison

CPT Pharmacometrics Syst Pharmacol· October 2025

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PBPK Modeling to Support Bioavailability and Bioequivalence Assessment in Pediatric Populations.
Fang Wu, Eleftheria Tsakalozou, Gilbert J Burckart, Rebeka Žakelj, Lu Gaohua, Nikunjkumar Patel

Pharm Res· May 2025

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Advances in Physiologically Based Pharmacokinetic (PBPK) Modeling and its Regulatory Utility to Support Oral Drug Product Development and Harmonization.
Yi-Hsien Cheng, Sherin Thomas, Yu Chung Tsang, Susana Almeida, Muhammad Ashraf, Nikunjkumar Patel

Pharm Res· May 2025

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Using Model Master Files to Support Oral Drug Product Development and Regulatory Submissions.
Yi-Hsien Cheng, Arindom Pal, Rebecca Moody, Tycho Heimbach, Viera Lukacova, Nikunjkumar Patel

Pharm Res· May 2025

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PBBM Considerations for Base Models, Model Validation, and Application Steps: Workshop Summary Report.
Tycho Heimbach, Flora Musuamba Tshinanu, Kimberly Raines, Luiza Borges, Shinichi Kijima, Nikunjkumar Patel

Mol Pharm· November 2024

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Physiologically-based pharmacokinetic model of sparsentan to evaluate drug-drug interaction potential.
Nikunjkumar K Patel, Kuan-Fu Chen, Shang-Chiung Chen, Kai Liu

CPT Pharmacometrics Syst Pharmacol· February 2024

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Physiologically Based Pharmacokinetic Model Development and Verification for Bioequivalence Testing of Bempedoic Acid Oral Suspension and Reference Tablet Formulation.
Benny M Amore, Nikunjkumar Patel, Priya Batheja, Ian E Templeton, Hannah M Jones

Pharmaceutics· May 2023

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Multi-phase multi-layer mechanistic dermal absorption (MPML MechDermA) model to predict local and systemic exposure of drug products applied on skin.
Nikunjkumar Patel, James F Clarke, Farzaneh Salem, Tariq Abdulla, Frederico Martins

CPT Pharmacometrics Syst Pharmacol· August 2022

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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.
Margareta Bego, Nikunjkumar Patel, Rodrigo Cristofoletti, Amin Rostami-Hodjegan

AAPS J· January 2022

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Ribavirin as a curative and prophylactic agent against foot and mouth disease virus infection in C57BL/6 suckling and adult mice model.
Patel Nikunjkumar, Ramasamy Periyasamy Tamil Selvan, Veerakyathappa Bhanuprakash

Virusdisease· December 2021

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Retrospective analysis of anti-inflammatory therapies during the first wave of COVID-19 at a community hospital.
Jose I Iglesias, Andrew V Vassallo, Jesse B Sullivan, Yasmine Elbaga, Vishal V Patel, Nikunjkumar Patel

World J Crit Care Med· September 2021

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Development and Qualification of a Physiologically Based Pharmacokinetic Model of Finasteride and Minoxidil Following Scalp Application.
Arpar Ngampanya, Udomsak Udomnilobol, Pakawadee Sermsappasuk, Natapol Pornputtapong, Boonsri Ongpipattanakul, Nikunjkumar Patel

J Pharm Sci· May 2021

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Best Practices in the Development and Validation of Physiologically Based Biopharmaceutics Modeling. A Workshop Summary Report.
Neil Parrott, Sandra Suarez-Sharp, Filippos Kesisoglou, Shriram M Pathak, David Good, Nikunjkumar Patel

J Pharm Sci· February 2021

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Packed Red Blood Cell Transfusion as a Potential Treatment Option in COVID-19 Patients With Hypoxemic Respiratory Failure: A Case Report.
Teshager Ejigu, Nikunjkumar Patel, Anuradha Sharma, Jagan Mohan Rao Vanjarapu, Vinod Nookala

Cureus· June 2020

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Integrating Drug- and Formulation-Related Properties With Gastrointestinal Tract Variability Using a Product-Specific Particle Size Approach: Case Example Ibuprofen.
Rodrigo Cristofoletti, Bart Hens, Nikunjkumar Patel, Valvanera Vozmediano Esteban, Stephan Schmidt

J Pharm Sci· December 2019

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Combining biorelevant in vitro and in silico tools to simulate and better understand the in vivo performance of a nano-sized formulation of aprepitant in the fasted and fed states.
Chara Litou, Nikunjkumar Patel, David B Turner, Edmund Kostewicz, Martin Kuentz

Eur J Pharm Sci· October 2019

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Dissolution and Translational Modeling Strategies Toward Establishing an In Vitro-In Vivo Link-a Workshop Summary Report.
Tycho Heimbach, Sandra Suarez-Sharp, Maziar Kakhi, Nico Holmstock, Andrés Olivares-Morales, Nikunjkumar Patel

AAPS J· February 2019

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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.
Nikunjkumar Patel, Barbara Wisniowska, Sebastian Polak

AAPS J· July 2018

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Quantitative approach for cardiac risk assessment and interpretation in tuberculosis drug development.
Sebastian Polak, Klaus Romero, Alexander Berg, Nikunjkumar Patel, Masoud Jamei

J Pharmacokinet Pharmacodyn· June 2018

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Towards Bridging Translational Gap in Cardiotoxicity Prediction: an Application of Progressive Cardiac Risk Assessment Strategy in TdP Risk Assessment of Moxifloxacin.
Nikunjkumar Patel, Oliver Hatley, Alexander Berg, Klaus Romero, Barbara Wisniowska

AAPS J· March 2018

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Model-Based Analysis of Biopharmaceutic Experiments To Improve Mechanistic Oral Absorption Modeling: An Integrated in Vitro in Vivo Extrapolation Perspective Using Ketoconazole as a Model Drug.
Shriram M Pathak, Aaron Ruff, Edmund S Kostewicz, Nikunjkumar Patel, David B Turner

Mol Pharm· December 2017

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In Silico Modeling Approach for the Evaluation of Gastrointestinal Dissolution, Supersaturation, and Precipitation of Posaconazole.
Bart Hens, Shriram M Pathak, Amitava Mitra, Nikunjkumar Patel, Bo Liu, Sanjaykumar Patel

Mol Pharm· December 2017

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Virtual bioequivalence for achlorhydric subjects: The use of PBPK modelling to assess the formulation-dependent effect of achlorhydria.
Kosuke Doki, Adam S Darwich, Nikunjkumar Patel, Amin Rostami-Hodjegan

Eur J Pharm Sci· November 2017

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Real Patient and its Virtual Twin: Application of Quantitative Systems Toxicology Modelling in the Cardiac Safety Assessment of Citalopram.
Nikunjkumar Patel, Barbara Wiśniowska, Masoud Jamei, Sebastian Polak

AAPS J· November 2017

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Does size matter? Kidney transplant donor size determines kidney function among living donors.
Meenakshi Narasimhamurthy, Lachlan M Smith, Jason T Machan, Steven E Reinert, Reginald Y Gohh, Nikunjkumar Patel

Clin Kidney J· February 2017

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