Works by Lukacova, Viera

Results: 31

Effect of Hepatic Impairment on Trofinetide Exposures Using an In Silico Physiologically Based Pharmacokinetic Model.

Published in:

Advances in Therapy, 2024, v. 41, n. 8, p. 3328, doi. 10.1007/s12325-024-02926-6

By:

Darwish, Mona;
Obianom, Obinna N.;
Youakim, James M.;
Darling, Inger;
Lukacova, Viera;
Bradley, Heather

Publication type:

Article

Quantitative clinical pharmacology for size and age scaling in pediatric drug development: A systematic review.

Published in:

Journal of Clinical Pharmacology, 2015, v. 55, n. 11, p. 1207, doi. 10.1002/jcph.555

By:

Samant, Tanay S.;
Mangal, Naveen;
Lukacova, Viera;
Schmidt, Stephan

Publication type:

Article

Binding of Matrix Metalloproteinase Inhibitors to Extracellular Matrix: 3D-QSAR Analysis.

Published in:

Chemical Biology & Drug Design, 2008, v. 72, n. 4, p. 237, doi. 10.1111/j.1747-0285.2008.00710.x

By:

Zhang, Yufen;
Lukacova, Viera;
Bartus, Vladimir;
Nie, Xiaoping;
Sun, Guorong;
Manivannan, Ethirajan;
Ghorpade, Sandeep R.;
Jin, Xiaomin;
Manyem, Shankar;
Sibi, Mukund P.;
Cook, Gregory R.;
Balaz, Stefan

Publication type:

Article

Drug–drug interaction prediction of ziritaxestat using a physiologically based enzyme and transporter pharmacokinetic network interaction model.

Published in:

CTS: Clinical & Translational Science, 2023, v. 16, n. 11, p. 2222, doi. 10.1111/cts.13622

By:

Perrier, Jeremy;
Gualano, Virginie;
Helmer, Eric;
Namour, Florence;
Lukacova, Viera;
Taneja, Amit

Publication type:

Article

Development of PBPK model for intra-articular injection in human: methotrexate solution and rheumatoid arthritis case study.

Published in:

Journal of Pharmacokinetics & Pharmacodynamics, 2021, v. 48, n. 6, p. 909, doi. 10.1007/s10928-021-09781-w

By:

Le Merdy, Maxime;
Mullin, Jim;
Lukacova, Viera

Publication type:

Article

Physiologically Based Pharmacokinetic Modelling for First-In-Human Predictions: An Updated Model Building Strategy Illustrated with Challenging Industry Case Studies.

Published in:

2019

By:

Miller, Neil A.;
Reddy, Micaela B.;
Heikkinen, Aki T.;
Lukacova, Viera;
Parrott, Neil

Publication type:

journal article

Clinical Ocular Exposure Extrapolation for Ophthalmic Solutions Using PBPK Modeling and Simulation.

Published in:

Pharmaceutical Research, 2023, v. 40, n. 2, p. 431, doi. 10.1007/s11095-022-03390-z

By:

Le Merdy, Maxime;
AlQaraghuli, Farah;
Tan, Ming-Liang;
Walenga, Ross;
Babiskin, Andrew;
Zhao, Liang;
Lukacova, Viera

Publication type:

Article

Ocular Physiologically Based Pharmacokinetic Modeling for Ointment Formulations.

Published in:

Pharmaceutical Research, 2020, v. 37, n. 12, p. 1, doi. 10.1007/s11095-020-02965-y

By:

Le Merdy, Maxime;
Spires, Jessica;
Lukacova, Viera;
Tan, Ming-Liang;
Babiskin, Andrew;
Xu, Xiaoming;
Zhao, Liang;
Bolger, Michael B.

Publication type:

Article

Public Workshop Summary Report on Fiscal Year 2021 Generic Drug Regulatory Science Initiatives: Data Analysis and Model‐Based Bioequivalence.

Published in:

Clinical Pharmacology & Therapeutics, 2021, v. 110, n. 5, p. 1190, doi. 10.1002/cpt.2120

By:

Lee, Jieon;
Gong, Yuqing;
Bhoopathy, Sid;
DiLiberti, Charles E.;
Hooker, Andrew C.;
Rostami‐Hodjegan, Amin;
Schmidt, Stephan;
Suarez‐Sharp, Sandra;
Lukacova, Viera;
Fang, Lanyan;
Zhao, Liang

Publication type:

Article

Physiologically Based Pharmacokinetic Absorption Model for Pexidartinib to Evaluate the Impact of Meal Contents and Intake Timing on Drug Exposure.

Published in:

Clinical Pharmacology in Drug Development, 2024, v. 13, n. 4, p. 440, doi. 10.1002/cpdd.1385

By:

Nakayama, Shintaro;
Lukacova, Viera;
Tanabe, Shuichi;
Watanabe, Akiko;
Mullin, Jim;
Suarez‐Sharp, Sandra;
Shimizu, Takako

Publication type:

Article

Model‐Informed Drug Development for Long‐Acting Injectable Products: Summary of American College of Clinical Pharmacology Symposium.

Published in:

Clinical Pharmacology in Drug Development, 2021, v. 10, n. 3, p. 220, doi. 10.1002/cpdd.928

By:

Sharan, Satish;
Fang, Lanyan;
Lukacova, Viera;
Chen, Xiaomei;
Hooker, Andrew C.;
Karlsson, Mats O.

Publication type:

Article

Leveraging Omeprazole PBPK/PD Modeling to Inform Drug–Drug Interactions and Specific Recommendations for Pediatric Labeling.

Published in:

Pharmaceutics, 2025, v. 17, n. 3, p. 373, doi. 10.3390/pharmaceutics17030373

By:

Soliman, Amira;
Rodriguez-Vera, Leyanis;
Alarcia-Lacalle, Ana;
Pippa, Leandro F.;
Subhani, Saima;
Lukacova, Viera;
Duconge, Jorge;
de Moraes, Natalia V.;
Vozmediano, Valvanera

Publication type:

Article

Physiologically Based Pharmacokinetic Models for Infliximab, Ipilimumab, and Nivolumab Developed with GastroPlus to Predict Hepatic Concentrations.

Published in:

Pharmaceutics, 2025, v. 17, n. 3, p. 372, doi. 10.3390/pharmaceutics17030372

By:

Vallejo, Celeste;
Meaney, Cameron;
Clemens, Lara;
Yang, Kyunghee;
Lukacova, Viera;
Zhou, Haiying

Publication type:

Article

Clinical Ocular Exposure Extrapolation for a Complex Ophthalmic Suspension Using Physiologically Based Pharmacokinetic Modeling and Simulation.

Published in:

2024

By:

Le Merdy, Maxime;
Spires, Jessica;
Tan, Ming-Liang;
Zhao, Liang;
Lukacova, Viera

Publication type:

Case Study

Applying Physiologically Based Pharmacokinetic Modeling to Interpret Carbamazepine's Nonlinear Pharmacokinetics and Its Induction Potential on Cytochrome P450 3A4 and Cytochrome P450 2C9 Enzymes.

Published in:

Pharmaceutics, 2024, v. 16, n. 6, p. 737, doi. 10.3390/pharmaceutics16060737

By:

Yin, Xuefen;
Cicali, Brian;
Rodriguez-Vera, Leyanis;
Lukacova, Viera;
Cristofoletti, Rodrigo;
Schmidt, Stephan

Publication type:

Article

Development of Mechanistic In Vitro–In Vivo Extrapolation to Support Bioequivalence Assessment of Long-Acting Injectables.

Published in:

Pharmaceutics, 2024, v. 16, n. 4, p. 552, doi. 10.3390/pharmaceutics16040552

By:

Amaral Silva, Daniela;
Le Merdy, Maxime;
Alam, Khondoker Dedarul;
Wang, Yan;
Bao, Quanying;
Malavia, Nilesh;
Burgess, Diane;
Lukacova, Viera

Publication type:

Article

PBPK Modeling Approach to Predict the Behavior of Drugs Cleared by Metabolism in Pregnant Subjects and Fetuses.

Published in:

Pharmaceutics, 2024, v. 16, n. 1, p. 96, doi. 10.3390/pharmaceutics16010096

By:

Le Merdy, Maxime;
Szeto, Ke Xu;
Perrier, Jeremy;
Bolger, Michael B.;
Lukacova, Viera

Publication type:

Article

Comprehensive Physiologically Based Pharmacokinetic Model to Assess Drug–Drug Interactions of Phenytoin.

Published in:

Pharmaceutics, 2023, v. 15, n. 10, p. 2486, doi. 10.3390/pharmaceutics15102486

By:

Rodriguez-Vera, Leyanis;
Yin, Xuefen;
Almoslem, Mohammed;
Romahn, Karolin;
Cicali, Brian;
Lukacova, Viera;
Cristofoletti, Rodrigo;
Schmidt, Stephan

Publication type:

Article

Leveraging Physiologically Based Modelling to Provide Insights on the Absorption of Paliperidone Extended-Release Formulation under Fed and Fasting Conditions.

Published in:

Pharmaceutics, 2023, v. 15, n. 2, p. 629, doi. 10.3390/pharmaceutics15020629

By:

Subhani, Saima;
Lukacova, Viera;
Kim, Chaejin;
Rodriguez-Vera, Leyanis;
Muniz, Paula;
Rodriguez, Monica;
Cristofoletti, Rodrigo;
Van Os, Sandra;
Suarez, Elena;
Schmidt, Stephan;
Vozmediano, Valvanera

Publication type:

Article

PBPK Modeling as a Tool for Predicting and Understanding Intestinal Metabolism of Uridine 5′-Diphospho-glucuronosyltransferase Substrates.

Published in:

Pharmaceutics, 2021, v. 13, n. 9, p. 1325, doi. 10.3390/pharmaceutics13091325

By:

Reddy, Micaela B.;
Bolger, Michael B.;
Fraczkiewicz, Grace;
Del Frari, Laurence;
Luo, Laibin;
Lukacova, Viera;
Mitra, Amitava;
Macwan, Joyce S.;
Mullin, Jim M.;
Parrott, Neil;
Heikkinen, Aki T.

Publication type:

Article

The Role of Model Master Files for Sharing, Acceptance, and Communication with FDA.

Published in:

AAPS Journal, 2024, v. 26, n. 2, p. 1, doi. 10.1208/s12248-024-00897-8

By:

Fang, Lanyan;
Gong, Yuqing;
Hooker, Andrew C.;
Lukacova, Viera;
Rostami-Hodjegan, Amin;
Sale, Mark;
Grosser, Stella;
Jereb, Rebeka;
Savic, Rada;
Peck, Carl;
Zhao, Liang

Publication type:

Article

Long-Acting Injectable Aqueous Suspensions—Summary From an AAPS Workshop.

Published in:

AAPS Journal, 2023, v. 25, n. 3, p. 1, doi. 10.1208/s12248-023-00811-8

By:

Holm, René;
Lee, Robert W.;
Glassco, Joey;
DiFranco, Nicholas;
Bao, Quanying;
Burgess, Diane J.;
Lukacova, Viera;
Alidori, Simone

Publication type:

Article

PBPK Modeling Approach to Predict the Behavior of Drugs Cleared by Kidney in Pregnant Subjects and Fetus.

Published in:

AAPS Journal, 2021, v. 23, n. 4, p. 1, doi. 10.1208/s12248-021-00603-y

By:

Szeto, Ke Xu;
Le Merdy, Maxime;
Dupont, Benjamin;
Bolger, Michael B.;
Lukacova, Viera

Publication type:

Article

Application of Mechanistic Ocular Absorption Modeling and Simulation to Understand the Impact of Formulation Properties on Ophthalmic Bioavailability in Rabbits: a Case Study Using Dexamethasone Suspension.

Published in:

AAPS Journal, 2019, v. 21, n. 4, p. 1, doi. 10.1208/s12248-019-0334-x

By:

Le Merdy, Maxime;
Fan, Jianghong;
Bolger, Michael B.;
Lukacova, Viera;
Spires, Jessica;
Tsakalozou, Eleftheria;
Patel, Vikram;
Xu, Lin;
Stewart, Sharron;
Chockalingam, Ashok;
Narayanasamy, Suresh;
Rouse, Rodney;
Matta, Murali;
Babiskin, Andrew;
Kozak, Darby;
Choi, Stephanie;
Zhang, Lei;
Lionberger, Robert;
Zhao, Liang

Publication type:

Article

Erratum to: Use of Modeling and Simulation Tools for Understanding the Impact of Formulation on the Absorption of a Low Solubility Compound: Ciprofloxacin.

Published in:

2016

By:

Martinez, Marilyn;
Mistry, Bipin;
Lukacova, Viera;
Polli, James;
Hoag, Stephen;
Dowling, Thomas;
Kona, Ravikanth;
Fahmy, Raafat

Publication type:

Erratum

Use of Modeling and Simulation Tools for Understanding the Impact of Formulation on the Absorption of a Low Solubility Compound: Ciprofloxacin.

Published in:

AAPS Journal, 2016, v. 18, n. 4, p. 886, doi. 10.1208/s12248-016-9913-2

By:

Martinez, Marilyn;
Mistry, Bipin;
Lukacova, Viera;
Polli, Jim;
Hoag, Stephen;
Dowling, Thomas;
Kona, Ravikanth;
Fahmy, Raafat

Publication type:

Article

Development of a Novel Oral Cavity Compartmental Absorption and Transit Model for Sublingual Administration: Illustration with Zolpidem.

Published in:

AAPS Journal, 2015, v. 17, n. 3, p. 631, doi. 10.1208/s12248-015-9727-7

By:

Xia, Binfeng;
Yang, Zhen;
Zhou, Haiying;
Lukacova, Viera;
Zhu, Wei;
Milewski, Mikolaj;
Kesisoglou, Filippos

Publication type:

Article

Simulations of the Nonlinear Dose Dependence for Substrates of Influx and Efflux Transporters in the Human Intestine.

Published in:

AAPS Journal, 2009, v. 11, n. 2, p. 353, doi. 10.1208/s12248-009-9111-6

By:

Bolger, Michael;
Lukacova, Viera;
Woltosz, Walter

Publication type:

Article

Prediction of Modified Release Pharmacokinetics and Pharmacodynamics from In Vitro, Immediate Release, and Intravenous Data.

Published in:

AAPS Journal, 2009, v. 11, n. 2, p. 323, doi. 10.1208/s12248-009-9107-2

By:

Lukacova, Viera;
Woltosz, Walter;
Bolger, Michael

Publication type:

Article

Correction to: Predicting Human Dermal Drug Concentrations Using PBPK Modeling and Simulation: Clobetasol Propionate Case Study.

Published in:

2024

By:

van Osdol, William W.;
Novakovic, Jasmina;
Le Merdy, Maxime;
Tsakalozou, Eleftheria;
Ghosh, Priyanka;
Spires, Jessica;
Lukacova, Viera

Publication type:

Correction Notice

Predicting Human Dermal Drug Concentrations Using PBPK Modeling and Simulation: Clobetasol Propionate Case Study.

Published in:

AAPS PharmSciTech, 2024, v. 25, n. 3, p. 1, doi. 10.1208/s12249-024-02740-x

By:

van Osdol, William W.;
Novakovic, Jasmina;
Le Merdy, Maxime;
Tsakalozou, Eleftheria;
Ghosh, Priyanka;
Spires, Jessica;
Lukacova, Viera

Publication type:

Article