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Journal articles on the topic 'PBPK/PD'

Author: Grafiati

Published: 3 June 2025

Last updated: 31 July 2025

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1

Mi, Kun, Shanju Pu, Yixuan Hou, et al. "Optimization and Validation of Dosage Regimen for Ceftiofur against Pasteurella multocida in Swine by Physiological Based Pharmacokinetic–Pharmacodynamic Model." International Journal of Molecular Sciences 23, no. 7 (2022): 3722. http://dx.doi.org/10.3390/ijms23073722.

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Model informed drug development is a valuable tool for drug development and clinical application due to its ability to integrate variability and uncertainty of data. This study aimed to determine an optimal dosage of ceftiofur against P. multocida by ex vivo pharmacokinetic/pharmacodynamic (PK/PD) model and validate the dosage regimens by Physiological based Pharmacokinetic-Pharmacodynamic (PBPK/PD) model. The pharmacokinetic profiles of ceftiofur both in plasma and bronchoalveolar lavage fluid (BALF) are determined. PD performance of ceftiofur against P. multocida was investigated. By establi

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Tanaka, Ryota, Kei Irie, and Tomoyuki Mizuno. "Physiologically Based Pharmacokinetic Modeling of Antibiotics in Children: Perspectives on Model-Informed Precision Dosing." Antibiotics 14, no. 6 (2025): 541. https://doi.org/10.3390/antibiotics14060541.

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The appropriate use of antibiotics is crucial and involves selecting an optimal dosing regimen based on pharmacokinetic (PK) and pharmacodynamic (PD) indicators. Physiologically based pharmacokinetic (PBPK) modeling is a powerful tool that integrates drugs’ physicochemical properties with anatomical and physiological data to predict PK behavior. In pediatric populations, PBPK modeling accounts for developmental changes in organ function, making it particularly useful for optimizing antibiotic dosing across different age groups, from neonates to adolescents. In recent decades, PBPK modeling has

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Witkowski, Jakub, Sebastian Polak, Zbigniew Rogulski, and Dariusz Pawelec. "In Vitro/In Vivo Translation of Synergistic Combination of MDM2 and MEK Inhibitors in Melanoma Using PBPK/PD Modelling: Part II." International Journal of Molecular Sciences 23, no. 19 (2022): 11939. http://dx.doi.org/10.3390/ijms231911939.

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The development of in vitro/in vivo translational methods for synergistically acting drug combinations is needed to identify the most effective therapeutic strategies. We performed PBPK/PD modelling for siremadlin, trametinib, and their combination at various dose levels and dosing schedules in an A375 xenografted mouse model (melanoma cells). In this study, we built models based on in vitro ADME and in vivo PK/PD data determined from the literature or estimated by the Simcyp Animal simulator (V21). The developed PBPK/PD models allowed us to account for the interactions between siremadlin and

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Jeong, Hyeon-Cheol, Min-Gul Kim, Zhuodu Wei, et al. "Integration of a Physiologically Based Pharmacokinetic and Pharmacodynamic Model for Tegoprazan and Its Metabolite: Application for Predicting Food Effect and Intragastric pH Alterations." Pharmaceutics 14, no. 6 (2022): 1298. http://dx.doi.org/10.3390/pharmaceutics14061298.

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A physiologically based pharmacokinetic/pharmacodynamic (PBPK/PD) model for tegoprazan and its major metabolite M1 was developed to predict PK and PD profiles under various scenarios. The PBPK model for tegoprazan and M1 was developed and predicted using the SimCYP® simulator and verified using clinical study data obtained after a single administration of tegoprazan. The established PBPK/PD model was used to predict PK profiles after repeated administrations of tegoprazan, postprandial PK profiles, and intragastric pH changes. The predicted tegoprazan and M1 concentration–time profiles fit the

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Witkowski, Jakub, Sebastian Polak, Dariusz Pawelec, and Zbigniew Rogulski. "In Vitro/In Vivo Translation of Synergistic Combination of MDM2 and MEK Inhibitors in Melanoma Using PBPK/PD Modelling: Part III." International Journal of Molecular Sciences 24, no. 3 (2023): 2239. http://dx.doi.org/10.3390/ijms24032239.

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The development of in vitro/in vivo translational methods and a clinical trial framework for synergistically acting drug combinations are needed to identify optimal therapeutic conditions with the most effective therapeutic strategies. We performed physiologically based pharmacokinetic–pharmacodynamic (PBPK/PD) modelling and virtual clinical trial simulations for siremadlin, trametinib, and their combination in a virtual representation of melanoma patients. In this study, we built PBPK/PD models based on data from in vitro absorption, distribution, metabolism, and excretion (ADME), and in vivo

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Kuepfer, L., C. Niederalt, T. Wendl, et al. "Applied Concepts in PBPK Modeling: How to Build a PBPK/PD Model." CPT: Pharmacometrics & Systems Pharmacology 5, no. 10 (2016): 516–31. http://dx.doi.org/10.1002/psp4.12134.

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RP, Sharma, Schuhmacher M, and Kumar V. "Developing integrated PBPK/PD coupled mechanistic pathway model (miRNA-BDNF): An approach towards system toxicology." Toxicol Lett 280 (October 5, 2017): 79–91. https://doi.org/10.1016/j.toxlet.2017.08.003.

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Integration of a dynamic signal transduction pathway into the tissue dosimetry model is a major advancement in the area of computational toxicology. This paper illustrates the ways to incorporate the use of existing system biological model in the field of toxicology via its coupling to the Physiological based Pharmacokinetics and Pharmacodynamics (PBPK/PD) model. This expansion framework of integrated PBPK/PD coupled mechanistic system pathway model can be called as system toxicology that describes the kinetics of both - the chemicals and - biomolecules, help us to understand the dynamic and s

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Loisios-Konstantinidis, Ioannis, Rodrigo Cristofoletti, Masoud Jamei, David Turner, and Jennifer Dressman. "Physiologically Based Pharmacokinetic/Pharmacodynamic Modeling to Predict the Impact of CYP2C9 Genetic Polymorphisms, Co-Medication and Formulation on the Pharmacokinetics and Pharmacodynamics of Flurbiprofen." Pharmaceutics 12, no. 11 (2020): 1049. http://dx.doi.org/10.3390/pharmaceutics12111049.

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Physiologically based pharmacokinetic/pharmacodynamic (PBPK/PD) models can serve as a powerful framework for predicting the influence as well as the interaction of formulation, genetic polymorphism and co-medication on the pharmacokinetics and pharmacodynamics of drug substances. In this study, flurbiprofen, a potent non-steroid anti-inflammatory drug, was chosen as a model drug. Flurbiprofen has absolute bioavailability of ~95% and linear pharmacokinetics in the dose range of 50–300 mg. Its absorption is considered variable and complex, often associated with double peak phenomena, and its pha

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Luecke, Richard H., Bruce A. Pearce, Walter D. Wosilait, Daniel R. Doerge, William Slikker, and John F. Young. "Windows based general PBPK/PD modeling software." Computers in Biology and Medicine 38, no. 9 (2008): 962–78. http://dx.doi.org/10.1016/j.compbiomed.2008.06.001.

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Qian, Lixuan, and Zhu Zhou. "Quantifying Heart Rate Changes After Delta-9-Tetrahydrocannabinol Administration Using a PBPK-PD Model in Healthy Adults." Pharmaceutics 17, no. 2 (2025): 237. https://doi.org/10.3390/pharmaceutics17020237.

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Background: As cannabis becomes legal in several U.S. states, the risk of THC-induced tachycardia increases. This study aimed to develop and verify a physiologically based pharmacokinetic–pharmacodynamic (PBPK-PD) model to assess the impact of THC and its active metabolite, 11-hydroxy-THC (11-OH-THC), on the heart rate of healthy adults. Methods: A PBPK-PD model for intravenous (IV) 11-OH-THC administration was first developed. Secondly, a PBPK-PD model for IV THC, combined with the metabolized 11-OH-THC, was established, verified, and validated. Direct PD models driven by the plasma, brain, a

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Jeong, Seung-Hyun, Ji-Hun Jang, and Yong-Bok Lee. "Torsemide Pharmacometrics in Healthy Adult Populations Including CYP2C9 Genetic Polymorphisms and Various Patient Groups through Physiologically Based Pharmacokinetic-Pharmacodynamic Modeling." Pharmaceutics 14, no. 12 (2022): 2720. http://dx.doi.org/10.3390/pharmaceutics14122720.

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Torsemide is a widely used diuretic in clinical practice. In this study, pharmacokinetic (PK) and pharmacodynamic (PD) simulations of torsemide for various population groups and exposure scenarios were performed through human-scale physiologically-based PK-PD (PBPK-PD) modeling of torsemide. For PBPK-PD modeling of torsemide, invitro and clinical data of torsemide reported previously were used. After exposure to clinical doses of torsemide, observed plasma (or serum) concentration and urine torsemide excretion profiles were used as PK-data, and observed urinary sodium excretion rate was used a

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Wei, Zhuodu, Hyeon-Cheol Jeong, Min-Gul Kim, and Kwang-Hee Shin. "Prediction of the Drug–Drug Interaction Potential between Tegoprazan and Amoxicillin/Clarithromycin Using the Physiologically Based Pharmacokinetic and Pharmacodynamic Model." Pharmaceuticals 16, no. 3 (2023): 360. http://dx.doi.org/10.3390/ph16030360.

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Tegoprazan is a novel potassium-competitive acid blocker. This study investigated the effect of drug–drug interaction on the pharmacokinetics and pharmacodynamics of tegoprazan co-administered with amoxicillin and clarithromycin, the first-line therapy for the eradication of Helicobacter pylori, using physiologically based pharmacokinetic and pharmacodynamic (PBPK/PD) modeling. The previously reported tegoprazan PBPK/PD model was modified and applied. The clarithromycin PBPK model was developed based on the model provided by the SimCYP® compound library. The amoxicillin model was constructed u

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Reig-López, Javier, María del Mar Maldonado, Matilde Merino-Sanjuan, et al. "Physiologically-Based Pharmacokinetic/Pharmacodynamic Model of MBQ-167 to Predict Tumor Growth Inhibition in Mice." Pharmaceutics 12, no. 10 (2020): 975. http://dx.doi.org/10.3390/pharmaceutics12100975.

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MBQ-167 is a dual inhibitor of the Rho GTPases Rac and Cdc42 that has shown promising results as an anti-cancer therapeutic at the preclinical stage. This drug has been tested in vitro and in vivo in metastatic breast cancer mouse models. The aim of this study is to develop a physiologically based pharmacokinetic/pharmacodynamic (PBPK-PD) model of MBQ-167 to predict tumor growth inhibition following intraperitoneal (IP) administration in mice bearing Triple Negative and HER2+ mammary tumors. PBPK and Simeoni tumor growth inhibition (TGI) models were developed using the Simcyp V19 Animal Simula

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Soliman, Amira, Leyanis Rodriguez-Vera, Ana Alarcia-Lacalle, et al. "Leveraging Omeprazole PBPK/PD Modeling to Inform Drug–Drug Interactions and Specific Recommendations for Pediatric Labeling." Pharmaceutics 17, no. 3 (2025): 373. https://doi.org/10.3390/pharmaceutics17030373.

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Background/Objectives: Omeprazole is widely used for managing gastrointestinal disorders like GERD, ulcers, and H. pylori infections. However, its use in pediatrics presents challenges due to drug interactions (DDIs), metabolic variability, and safety concerns. Omeprazole’s pharmacokinetics (PK), primarily influenced by CYP2C19 metabolism, is affected by ontogenetic changes in enzyme expression, complicating dosing in children. Methods: This study aimed to develop and validate a physiologically based pharmacokinetic (PBPK) model for omeprazole and its metabolites to predict age-related variati

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Liu, Xiaomei I. "Oxytocin Dosing and Maternal-Fetal Effects Using a Pharmacokinetic Model." Journal of Medical Research 9, no. 2 (2023): 26–29. http://dx.doi.org/10.31254/jmr.2023.9205.

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Objective- Although oxytocin is widely used in labor and childbirth, questions remain regarding the pharmacokinetics (PK), pharmacodynamics (PD) and dose of oxytocin in pregnant people as well as the potential effects on the fetus and newborn. The objective of the current study was to use published studies to investigate the PK/PD and dose of oxytocin in pregnancy, examine the placental transfer of oxytocin through the development of a physiologically-based PK (PBPK) model, and postulate whether the model predicts the effect(s) of oxytocin on fetuses and newborn infants. Methods- A literature

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Florian, J. A., M. J. Egorin, W. C. Zamboni, et al. "A physiologically-based pharmacokinetic (PBPK) and pharmacodynamic (PD) model of docetaxel (Doc) and neutropenia in humans." Journal of Clinical Oncology 25, no. 18_suppl (2007): 2567. http://dx.doi.org/10.1200/jco.2007.25.18_suppl.2567.

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2567 Background: We have scaled our previously described murine Doc PBPK model (Florian et. al, Proc. AACR, 2006) to humans to determine if it predicts human plasma Doc concentration. The resulting human plasma Doc predictions were then coupled to a low- order neutrophil model from the literature (Karlsson et. al, Clin. Cancer Res., 2006), and individual patient absolute neutrophil count (ANC) predictions were compared with actual ANC data. Methods: Plasma Doc concentration vs. time data were obtained from 75 patients given 1-h Doc infusions and sampled out to 48 h. 67 patients received 50–75

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Cordes, Henrik, Christoph Thiel, Hélène E. Aschmann, Vanessa Baier, Lars M. Blank, and Lars Kuepfer. "A Physiologically Based Pharmacokinetic Model of Isoniazid and Its Application in Individualizing Tuberculosis Chemotherapy." Antimicrobial Agents and Chemotherapy 60, no. 10 (2016): 6134–45. http://dx.doi.org/10.1128/aac.00508-16.

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ABSTRACTDue to its high early bactericidal activity, isoniazid (INH) plays an essential role in tuberculosis treatment. Genetic polymorphisms ofN-acetyltransferase type 2 (NAT2) cause a trimodal distribution of INH pharmacokinetics in slow, intermediate, and fast acetylators. The success of INH-based chemotherapy is associated with acetylator and patient health status. Still, a standard dose recommended by the FDA is administered regardless of acetylator type or immune status, even though adverse effects occur in 5 to 33% of all patients. Slow acetylators have a higher risk of development of d

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Lee, Byeong ill, Min-Ho Park, Seok-Ho Shin, et al. "Quantitative Analysis of Tozadenant Using Liquid Chromatography-Mass Spectrometric Method in Rat Plasma and Its Human Pharmacokinetics Prediction Using Physiologically Based Pharmacokinetic Modeling." Molecules 24, no. 7 (2019): 1295. http://dx.doi.org/10.3390/molecules24071295.

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Tozadenant is one of the selective adenosine A2a receptor antagonists with a potential to be a new Parkinson’s disease (PD) therapeutic drug. In this study, a liquid chromatography-mass spectrometry based bioanalytical method was qualified and applied for the quantitative analysis of tozadenant in rat plasma. A good calibration curve was observed in the range from 1.01 to 2200 ng/mL for tozadenant using a quadratic regression. In vitro and preclinical in vivo pharmacokinetic (PK) properties of tozadenant were studied through the developed bioanalytical methods, and human PK profiles were predi

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Kim, Min-Soo, Nora Lee, Areum Lee, Yoon-Jee Chae, Suk-Jae Chung, and Kyeong-Ryoon Lee. "Model-Based Prediction of Acid Suppression and Proposal of a New Dosing Regimen of Fexuprazan in Humans." Pharmaceuticals 15, no. 6 (2022): 709. http://dx.doi.org/10.3390/ph15060709.

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Fexuprazan is a potassium-competitive acid blocker (P-CAB). The compounds in this newly developed drug family suppress intragastric acidity. As there are already other acid-suppressing drugs on the market, such as H2 antagonists and proton pump inhibitors (PPIs), it would be informative to compare the biological effects of fexuprazan against another approved drug with the same indication. The drug concentration predicted by the pharmacokinetic (PK) model could serve as an input function for a pharmacodynamic (PD) model. The apparent pharmacokinetics of fexuprazan could be described by a simple

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Poet, Torka S., Charles Timchalk, Jon A. Hotchkiss, and Michael J. Bartels. "Chlorpyrifos PBPK/PD model for multiple routes of exposure." Xenobiotica 44, no. 10 (2014): 868–81. http://dx.doi.org/10.3109/00498254.2014.918295.

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Schaller, Stephan, Jorg Lippert, Lukas Schaupp, Thomas R. Pieber, Andreas Schuppert, and Thomas Eissing. "Robust PBPK/PD-Based Model Predictive Control of Blood Glucose." IEEE Transactions on Biomedical Engineering 63, no. 7 (2016): 1492–504. http://dx.doi.org/10.1109/tbme.2015.2497273.

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Esposito, Simone, and David Cebrián. "Translational PBPK/PD modeling in drug discovery: A CRO perspective." Drug Discovery Today 30, no. 8 (2025): 104427. https://doi.org/10.1016/j.drudis.2025.104427.

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Salim, Emilie Langeskov, Kim Kristensen, and Erik Sjögren. "Whole-Body Physiologically Based Pharmacokinetic Modeling of GalNAc-Conjugated siRNAs." Pharmaceutics 17, no. 1 (2025): 69. https://doi.org/10.3390/pharmaceutics17010069.

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Background/Objectives: N-acetyl-galactosamine small interfering RNAs (GalNAc-siRNA) are an emerging class of drugs due to their durable knockdown of disease-related proteins. Direct conjugation of GalNAc onto the siRNA enables targeted uptake into hepatocytes via GalNAc recognition of the Asialoglycoprotein Receptor (ASGPR). With a transient plasma exposure combined with a prolonged liver half-life, GalNAc-siRNA exhibits distinct disposition characteristics. We aimed to develop a generic GalNAc-siRNAs whole-body physiologically based pharmacokinetic–pharmacodynamic (WB-PBPK-PD) model for descr

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Vallejo, Celeste, Cameron Meaney, Lara Clemens, Kyunghee Yang, Viera Lukacova, and Haiying Zhou. "Physiologically Based Pharmacokinetic Models for Infliximab, Ipilimumab, and Nivolumab Developed with GastroPlus to Predict Hepatic Concentrations." Pharmaceutics 17, no. 3 (2025): 372. https://doi.org/10.3390/pharmaceutics17030372.

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Background/Objectives: Infliximab, ipilimumab, and nivolumab are three monoclonal antibodies that have been associated with hepatotoxicity. Three separate physiologically based pharmacokinetic (PBPK) models were developed in GastroPlus® to simulate plasma and liver concentrations in patient populations after administration of either infliximab, ipilimumab, or nivolumab. Methods: The models include distribution and clearance mechanisms specific to large molecules, FcRn binding dynamics, and target-mediated drug disposition (TNF-α for infliximab, CTLA-4 for ipilimumab, and PD-1 for nivolumab). R

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Abdulsamed, Mohamed, Ashraf A Naass, Mohamed S. A. Eswani, Mohamed O Elbasir, and Sedigh Bashir. "Advancing Precision Drug Therapy in Pregnant Women: PBPK Modeling of Antiviral Drugs." Translational Medicine: Open Access 2, no. 2 (2024): 01–17. https://doi.org/10.33140/tmoa.02.02.01.

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PBPK/PD modeling is essential in modern drug development. Traditional drug development methods frequently rely on trial and error, which can be time-consuming, costly, and could be risky. Predicting pharmacokinetics (PK) of drugs in pregnant women, encompassing the intricate aspect of placental drug transfer, remains a complex task. This study was to compare of simulated or predicted and observed (previously published approaches) pharmacokinetic parameters among the four antiviral drugs in pregnant and non-pregnant women. In addition, this investigation endeavors to construct and assess physio

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Kovar, Lukas, Dominik Selzer, Hannah Britz, et al. "Comprehensive Parent–Metabolite PBPK/PD Modeling Insights into Nicotine Replacement Therapy Strategies." Clinical Pharmacokinetics 59, no. 9 (2020): 1119–34. http://dx.doi.org/10.1007/s40262-020-00880-4.

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German, Carrie, Minu Pilvankar, and Andrzej Przekwas. "Computational framework for predictive PBPK-PD-Tox simulations of opioids and antidotes." Journal of Pharmacokinetics and Pharmacodynamics 46, no. 6 (2019): 513–29. http://dx.doi.org/10.1007/s10928-019-09648-1.

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Witkowski, Jakub, Sebastian Polak, Zbigniew Rogulski, and Dariusz Pawelec. "In Vitro/In Vivo Translation of Synergistic Combination of MDM2 and MEK Inhibitors in Melanoma Using PBPK/PD Modelling: Part I." International Journal of Molecular Sciences 23, no. 21 (2022): 12984. http://dx.doi.org/10.3390/ijms232112984.

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Translation of the synergy between the Siremadlin (MDM2 inhibitor) and Trametinib (MEK inhibitor) combination observed in vitro into in vivo synergistic efficacy in melanoma requires estimation of the interaction between these molecules at the pharmacokinetic (PK) and pharmacodynamic (PD) levels. The cytotoxicity of the Siremadlin and Trametinib combination was evaluated in vitro in melanoma A375 cells with MTS and RealTime-Glo assays. Analysis of the drug combination matrix was performed using Synergy and Synergyfinder packages. Calculated drug interaction metrics showed high synergy between

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Dr., Yuvraj Kaushal*, and Pranav Goyal Dr. "OPTIMISING DRUG DEVELOPMENT- A DYNAMIC APPROACH WITH MODEL AND SIMULATION STRATEGIES." World Journal of Pharmaceutical Science and Research 3, no. 5 (2024): 365–70. https://doi.org/10.5281/zenodo.14025213.

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In 2021, the Food and Drug Administration recognized the potential of modeling and simulation (M&S) tools in enhancing drug policy development, postmarket product evaluation, and premarket analysis. While mathematical modeling isn't new to drug research, pharmacokinetic/pharmacodynamic (PK/PD) modeling uniquely examines the interactions between drug kinetics and dynamics in the body. PK modeling quantifies drug absorption and distribution, whereas PD modeling assesses the biological response over time. M&S techniques support various FDA centers, such as CDER, CDRH, and NCTR, in product

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Cheng, Yi-Hsien, Wei-Chun Chou, Ying-Fei Yang, et al. "PBPK/PD assessment for Parkinson’s disease risk posed by airborne pesticide paraquat exposure." Environmental Science and Pollution Research 25, no. 6 (2017): 5359–68. http://dx.doi.org/10.1007/s11356-017-0875-4.

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Prado-Velasco, Manuel. "Modular dynamics paradigm in biosystems multilevel modeling: Software design and PBPK/PD validation." Computers in Biology and Medicine 188 (April 2025): 109856. https://doi.org/10.1016/j.compbiomed.2025.109856.

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Wiśniowska, Barbara, Joanna Giebułtowicz, Roman Piotrowski, Piotr Kułakowski, and Sebastian Polak. "Development and Performance Verification of the PBPK Model for Antazoline and Its Metabolite and Its Utilization for Pharmacological Hypotheses Formulating." Pharmaceuticals 15, no. 3 (2022): 379. http://dx.doi.org/10.3390/ph15030379.

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Antazoline is an antihistaminic drug that is effective in the termination of paroxysmal atrial fibrillation. Despite its long presence in the market, antazoline’s ADME parameters and pharmacokinetic effects in humans are poorly characterized. The objective of this study was to fill this gap by generation of in vitro and in vivo data and the development of a physiologically based pharmacokinetic model describing antazoline and its main metabolite disposition. A set of ADME parameters for the antazoline and its hydroxy metabolite is provided based on literature data, QSAR predictions, in vitro b

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Uppalapati, Dedeepya, Nihar R. Das, Rahul P. Gangwal, Mangesh V. Damre, Abhay T. Sangamwar та Shyam S. Sharma. "Neuroprotective Potential of Peroxisome Proliferator Activated Receptor-αAgonist in Cognitive Impairment in Parkinson’s Disease: Behavioral, Biochemical, and PBPK Profile". PPAR Research 2014 (2014): 1–9. http://dx.doi.org/10.1155/2014/753587.

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Parkinson’s disease (PD) is a common neurodegenerative disorder affecting 1% of the population by the age of 65 years and 4-5% of the population by the age of 85 years. PD affects functional capabilities of the patient by producing motor symptoms and nonmotor symptoms. Apart from this, it is also associated with a higher risk of cognitive impairment that may lead to memory loss, confusion, and decreased attention span. In this study, we have investigated the effect of fenofibrate, a PPAR-αagonist in cognitive impairment model in PD. Bilateral intranigral administration of 1-methyl-4-phenyl-1,2

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Świerczek, Artur, Dominika Batko, and Elżbieta Wyska. "The Role of Pharmacometrics in Advancing the Therapies for Autoimmune Diseases." Pharmaceutics 16, no. 12 (2024): 1559. https://doi.org/10.3390/pharmaceutics16121559.

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Autoimmune diseases (AIDs) are a group of disorders in which the immune system attacks the body’s own tissues, leading to chronic inflammation and organ damage. These diseases are difficult to treat due to variability in drug PK among individuals, patient responses to treatment, and the side effects of long-term immunosuppressive therapies. In recent years, pharmacometrics has emerged as a critical tool in drug discovery and development (DDD) and precision medicine. The aim of this review is to explore the diverse roles that pharmacometrics has played in addressing the challenges associated wi

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Yang, R. S., R. S. Thomas, D. L. Gustafson, et al. "Approaches to developing alternative and predictive toxicology based on PBPK/PD and QSAR modeling." Environmental Health Perspectives 106, suppl 6 (1998): 1385–93. http://dx.doi.org/10.1289/ehp.98106s61385.

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Foxenberg, Robert J., Corie A. Ellison, James B. Knaak, Changxing Ma, and James R. Olson. "Cytochrome P450-specific human PBPK/PD models for the organophosphorus pesticides: Chlorpyrifos and parathion." Toxicology 285, no. 1-2 (2011): 57–66. http://dx.doi.org/10.1016/j.tox.2011.04.002.

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Ling, M. P., and C. M. Liao. "A Human PBPK/PD Model to Assess Arsenic Exposure Risk Through Farmed Tilapia Consumption." Bulletin of Environmental Contamination and Toxicology 83, no. 1 (2009): 108–14. http://dx.doi.org/10.1007/s00128-009-9764-y.

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Litjens, Carlijn H. C., Laurens F. M. Verscheijden, Elin M. Svensson, et al. "Physiologically-Based Pharmacokinetic Modelling to Predict the Pharmacokinetics and Pharmacodynamics of Linezolid in Adults and Children with Tuberculous Meningitis." Antibiotics 12, no. 4 (2023): 702. http://dx.doi.org/10.3390/antibiotics12040702.

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Linezolid is used off-label for treatment of central nervous system infections. However, its pharmacokinetics and target attainment in cranial cerebrospinal fluid (CSF) in tuberculous meningitis patients is unknown. This study aimed to predict linezolid cranial CSF concentrations and assess attainment of pharmacodynamic (PD) thresholds (AUC:MIC of >119) in plasma and cranial CSF of adults and children with tuberculous meningitis. A physiologically based pharmacokinetic (PBPK) model was developed to predict linezolid cranial CSF profiles based on reported plasma concentrations. Simulated ste

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Sharma, Raju Prasad, Marta Schuhmacher, and Vikas Kumar. "Developing integrated PBPK/PD coupled mechanistic pathway model (miRNA-BDNF): An approach towards system toxicology." Toxicology Letters 280 (October 2017): 79–91. http://dx.doi.org/10.1016/j.toxlet.2017.08.003.

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Sharma, R. Prasad, M. Nadal, M. Schuhmacher, J. Domingo, and V. Kumar. "Application of a PBPK/PD model to understand the neurotoxicity pathway of PFOS via microRNA." Toxicology Letters 258 (September 2016): S257. http://dx.doi.org/10.1016/j.toxlet.2016.06.1908.

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Poet, Torka S., Charles Timchalk, Michael J. Bartels, et al. "Use of a probabilistic PBPK/PD model to calculate Data Derived Extrapolation Factors for chlorpyrifos." Regulatory Toxicology and Pharmacology 86 (June 2017): 59–73. http://dx.doi.org/10.1016/j.yrtph.2017.02.014.

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Housand, Conrad, Nil Roy, Tine Wyseure, et al. "Abstract C126: Translational pharmacokinetic/pharmacodynamic (PK/PD) modeling of novel covalent Kelch-like ECH-associated protein 1 (KEAP1) activators." Molecular Cancer Therapeutics 22, no. 12_Supplement (2023): C126. http://dx.doi.org/10.1158/1535-7163.targ-23-c126.

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Abstract Introduction: The KEAP1-nuclear factor erythroid 2-related factor 2 (NRF2) signaling axis is a key homeostatic mechanism for cells to maintain redox balance. In oxidative stress, reactive oxygen species (ROS) modify residues on KEAP1, impairing its binding and ubiquitination of NRF2. This leads to an accumulation and translocation of NRF2 to the nucleus where it increases transcription of genes for antioxidant response [Pillai 2022]. The KEAP1-NRF2 pathway is hijacked in cancers through NRF2 gain of function or KEAP1 loss of function mutations leading to aberrant activation of NRF2. W

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Housand, Conrad, Nil Roy, Tine Wyseure, et al. "Abstract 4349: Translational pharmacokinetic/pharmacodynamic (PK/PD) modeling for VVD-130037, a novel, first-in-class covalent small molecule Kelch-like ECH-associated protein 1 (KEAP1) activator." Cancer Research 85, no. 8_Supplement_1 (2025): 4349. https://doi.org/10.1158/1538-7445.am2025-4349.

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Introduction: The KEAP1-nuclear factor erythroid 2 (NRF2) pathway provides homeostatic mechanisms for oxidative stress response which can be activated in cancers. Vividion Therapeutics has developed novel allosteric molecular glues of the Keap1-CUL3 E3-ligase complex. Preclinically, these agents covalently target KEAP1-CUL3 E3 ligase and allosterically increase the affinity between KEAP1 and CUL3, promoting the formation of active KEAP1-CUL3 E3 ligase complexes and enhancing NRF2 degradation (Mol Cancer Ther (2023) 22 (12_Suppl): PR011). We established a translational PK/PD model for KEAP1 tar

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Mystridis, George A., Georgios C. Batzias, and Ioannis S. Vizirianakis. "Physiologically Based Pharmacokinetic Modelling and Simulation to Predict the Plasma Concentration Profile of Doxorubicin." Pharmaceutics 14, no. 3 (2022): 541. http://dx.doi.org/10.3390/pharmaceutics14030541.

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Doxorubicin (DOX) is still an important anticancer agent despite its tricky pharmacokinetics (PK) and toxicity potential. The advent of systems pharmacology enables the construction of PK models able to predict the concentration profiles of drugs and shed light on the underlying mechanisms involved in PK and pharmacodynamics (PD). By utilizing existing published data and by analysing two clinical case studies we attempt to create physiologically based pharmacokinetic (PBPK) models for DOX using widely accepted methodologies. Based on two different approaches on three different key points we de

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Shchelokov, Dmitry, Oleg Demin, Oleg Demin, et al. "Abstract 5421: Prediction of intratumoral TIGIT receptor occupancy after the treatment with anti-TIGIT antibodies." Cancer Research 82, no. 12_Supplement (2022): 5421. http://dx.doi.org/10.1158/1538-7445.am2022-5421.

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Abstract Background: T-cell immunoreceptor with immunoglobulin and tyrosine based inhibitory motif domain (TIGIT) is a co-inhibitory immune checkpoint receptor expressed on several types of immune cells, which can suppress T-cell activation, promote T-cell exhaustion, and suppress natural killer cell mediated cytotoxicity. Recent clinical data with anti-TIGIT monoclonal antibodies (mAbs) indicate that TIGIT blockade is a highly promising therapy when combined with PD-1/PD-L1 blockade. However, unlike PD-1 receptor occupancy (RO), there is a lack of information regarding RO in peripheral blood

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Paraiso, Rafael L. M., Rachel H. Rose, Nikoletta Fotaki, Mark McAllister, and Jennifer B. Dressman. "The use of PBPK/PD to establish clinically relevant dissolution specifications for zolpidem immediate release tablets." European Journal of Pharmaceutical Sciences 155 (December 2020): 105534. http://dx.doi.org/10.1016/j.ejps.2020.105534.

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Chowdary, Pratima, Toshko Jelev Lissitchkov, Stefan Willmann, Stephan Schwers, Lisa A. Michaels, and Anita Shah. "Pharmacodynamics, Pharmacokinetics and Safety of Bay 1093884, an Antibody Directed Against Human TFPI, in Patients with Factor VIII or IX Deficiency (With and Without Inhibitors): A Phase 1 Study." Blood 132, Supplement 1 (2018): 1176. http://dx.doi.org/10.1182/blood-2018-99-114683.

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Abstract Background: BAY 1093884 is a fully human monoclonal antibody directed against the K1 and K2 domains of human tissue factor pathway inhibitor (TFPI). TFPI regulates the initiation of coagulation and is important for regulation of normal hemostatic response. In factor (F)VIII and FIX deficiency (hemophilia A [HA] and B [HB], respectively), lack of adequate amplification (FXa generation) in tandem with intact regulation contributes to reduced clotting. Inhibition of TFPI has the potential to normalize coagulation in hemophilia even in the absence of FVIII or FIX and it is expected to res

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Barrera-Vazquez, Oscar, Jose Alberto Santiago-de-la-Cruz, Nadia Alejandra Rivero-Segura, et al. "Data-Driven Approaches Used for Compound Library Design for the Treatment of Parkinson’s Disease." International Journal of Molecular Sciences 24, no. 2 (2023): 1134. http://dx.doi.org/10.3390/ijms24021134.

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Parkinson’s disease (PD) is the second most common neurodegenerative disease in older individuals worldwide. Pharmacological treatment for such a disease consists of drugs such as monoamine oxidase B (MAO-B) inhibitors to increase dopamine concentration in the brain. However, such drugs have adverse reactions that limit their use for extended periods; thus, the design of less toxic and more efficient compounds may be explored. In this context, cheminformatics and computational chemistry have recently contributed to developing new drugs and the search for new therapeutic targets. Therefore, thr

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Chang, D., P. Egeghy, J. Knaak, et al. "Influence of Matrix Formulation on Dermal Percutaneous Absorption of Triazole Fungicides Using QSAR and PBPK/PD Models." Epidemiology 17, Suppl (2006): S470. http://dx.doi.org/10.1097/00001648-200611001-01262.

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Timchalk, C. "A Physiologically Based Pharmacokinetic and Pharmacodynamic (PBPK/PD) Model for the Organophosphate Insecticide Chlorpyrifos in Rats and Humans." Toxicological Sciences 66, no. 1 (2002): 34–53. http://dx.doi.org/10.1093/toxsci/66.1.34.

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