Relevant bibliographies by topics / Preclinical PK/PD

Contents

  1. Journal articles
  2. Dissertations / Theses
  3. Book chapters
  4. Conference papers

Academic literature on the topic 'Preclinical PK/PD'

Author: Grafiati
Published: 2 June 2025
Last updated: 31 July 2025

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Journal articles on the topic "Preclinical PK/PD"

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Hosseini, Iraj, Brett Fleisher, Jennifer Getz, et al. "A Minimal PBPK/PD Model with Expansion-Enhanced Target-Mediated Drug Disposition to Support a First-in-Human Clinical Study Design for a FLT3L-Fc Molecule." Pharmaceutics 16, no. 5 (2024): 660. http://dx.doi.org/10.3390/pharmaceutics16050660.

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FLT3L-Fc is a half-life extended, effectorless Fc-fusion of the native human FLT3-ligand. In cynomolgus monkeys, treatment with FLT3L-Fc leads to a complex pharmacokinetic/pharmacodynamic (PK/PD) relationship, with observed nonlinear PK and expansion of different immune cell types across different dose levels. A minimal physiologically based PK/PD model with expansion-enhanced target-mediated drug disposition (TMDD) was developed to integrate the molecule’s mechanism of action, as well as the complex preclinical and clinical PK/PD data, to support the preclinical-to-clinical translation of FLT
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Zalba, Sara, Ana M. Contreras-Sandoval, Eva Martisova, Reno Debets, Christian Smerdou, and María Jesús Garrido. "Quantification of Pharmacokinetic Profiles of PD-1/PD-L1 Antibodies by Validated ELISAs." Pharmaceutics 12, no. 6 (2020): 595. http://dx.doi.org/10.3390/pharmaceutics12060595.

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Immunotherapy has changed the paradigm of cancer treatments. In this way, several combinatorial strategies based on monoclonal antibodies (mAb) such as anti (a)-PD-1 or anti (a)-PD-L1 are often reported to yield promising clinical benefits. However, the pharmacokinetic (PK) behavior of these mAbs is a critical issue that requires selective analytical techniques. Indeed, few publications report data on a-PD1/a-PD-L1 exposure and its relationship with therapeutic or toxic effects. In this regard, preclinical assays allow the time profiles of antibody plasma concentrations to be characterized rap
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Na, Joo Young, Min Hai, Kyeongmin Kim, et al. "Translational Pharmacokinetic-Pharmacodynamic Modeling of a Novel Oral Dihydroorotate Dehydrogenase (DHODH) Inhibitor, HOSU-53 (JBZ-001)." Pharmaceutics 17, no. 4 (2025): 412. https://doi.org/10.3390/pharmaceutics17040412.

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Background: HOSU-53 (JBZ-001), an orally bioavailable new chemical entity, represents a highly potent dihydroorotate dehydrogenase (DHODH) inhibitor in late preclinical development for application in cancer therapy. Methods: Multiple Good Laboratory Practice (GLP) and non-GLP preclinical studies were conducted in mice, rats, and dogs. Plasma samples of HOSU-53 and dihydroorotate (DHO), the substrate of DHODH, were collected for pharmacokinetic (PK) and pharmacodynamic (PD) assessment and modeling. Two modeling approaches were utilized to understand the PK/PD properties of HOSU-53 and to recomm
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Cheng, Shen, Susheel Kumar Nethi, Mahmoud Al-Kofahi, and Swayam Prabha. "Pharmacokinetic—Pharmacodynamic Modeling of Tumor Targeted Drug Delivery Using Nano-Engineered Mesenchymal Stem Cells." Pharmaceutics 13, no. 1 (2021): 92. http://dx.doi.org/10.3390/pharmaceutics13010092.

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Nano-engineered mesenchymal stem cells (nano-MSCs) are promising targeted drug delivery platforms for treating solid tumors. MSCs engineered with paclitaxel (PTX) loaded poly(lactide-co-glycolide) (PLGA) nanoparticles (NPs) are efficacious in treating lung and ovarian tumors in mouse models. The quantitative description of pharmacokinetics (PK) and pharmacodynamics (PD) of nano-MSCs is crucial for optimizing their therapeutic efficacy and clinical translatability. However, successful translation of nano-MSCs is challenging due to their complex composition and physiological mechanisms regulatin
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Howard, Alex, and William Hope. "Assessment of Antifungal Pharmacodynamics." Journal of Fungi 9, no. 2 (2023): 192. http://dx.doi.org/10.3390/jof9020192.

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Pharmacokinetic-pharmacodynamic (PK-PD) analysis is of central importance to the progress of an antifungal agent into clinical use. It is crucial to ensure that preclinical studies give the best possible prediction of the way drugs are likely to behave in a clinical setting. This review details the last 30 years of progress in terms of disease model design, efficacy outcome selection and translational modelling in antifungal PK-PD studies. The principles of how PK-PD parameters inform current clinical practice are also discussed, including a review of how these apply to existing and novel agen
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Pasipanodya, Jotam, and Tawanda Gumbo. "An Oracle: Antituberculosis Pharmacokinetics-Pharmacodynamics, Clinical Correlation, and Clinical Trial Simulations To Predict the Future." Antimicrobial Agents and Chemotherapy 55, no. 1 (2010): 24–34. http://dx.doi.org/10.1128/aac.00749-10.

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ABSTRACTAntimicrobial pharmacokinetic-pharmacodynamic (PK/PD) science and clinical trial simulations have not been adequately applied to the design of doses and dose schedules of antituberculosis regimens because many researchers are skeptical about their clinical applicability. We compared findings of preclinical PK/PD studies of current first-line antituberculosis drugs to findings from several clinical publications that included microbiologic outcome and pharmacokinetic data or had a dose-scheduling design. Without exception, the antimicrobial PK/PD parameters linked to optimal effect were
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Tanaka, Chiaki, Terence O’Reilly, John M. Kovarik, et al. "Identifying Optimal Biologic Doses of Everolimus (RAD001) in Patients With Cancer Based on the Modeling of Preclinical and Clinical Pharmacokinetic and Pharmacodynamic Data." Journal of Clinical Oncology 26, no. 10 (2008): 1596–602. http://dx.doi.org/10.1200/jco.2007.14.1127.

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PurposeTo use preclinical and clinical pharmacokinetic (PK)/pharmacodynamic (PD) modeling to predict optimal clinical regimens of everolimus, a novel oral mammalian target of rapamycin (mTOR) inhibitor, to carry forward to expanded phase I with tumor biopsy studies in cancer patients.Patients and MethodsInhibition of S6 kinase 1 (S6K1), a molecular marker of mTOR signaling, was selected for PD analysis in peripheral blood mononuclear cells (PBMCs) in a phase I clinical trial. PK and PD were measured up to 11 days after the fourth weekly dose. A PK/PD model was used to describe the relationship
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Bajaj, Gaurav, Fereshteh Nazari, Marc Presler, et al. "786 Dose selection for DuoBody®-PD-L1×4-1BB (GEN1046) using a semimechanistic pharmacokinetics/pharmacodynamics model that leverages preclinical and clinical data." Journal for ImmunoTherapy of Cancer 9, Suppl 2 (2021): A821. http://dx.doi.org/10.1136/jitc-2021-sitc2021.786.

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BackgroundDuoBody-PD-L1×4-1BB (GEN1046) is a class-defining bispecific antibody, designed to elicit an anti-tumor immune response by simultaneous and complementary blockade of PD-L1 on tumor cells and conditional stimulation of 4-1BB on T-cells and NK cells. Optimizing target engagement for a bispecific antibody is challenging, as it involves binding with two targets, and predicting trimer levels in tumors based on affinity of individual arms and target expression. Here we describe a semimechanistic, physiologically based pharmacokinetic/pharmacodynamic (PK/PD) model that predicts a dosing reg
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Lindhardt, Emma, and Peter Gennemark. "Automated analysis of routinely generated preclinical pharmacokinetic and pharmacodynamic data." Journal of Bioinformatics and Computational Biology 12, no. 03 (2014): 1450010. http://dx.doi.org/10.1142/s0219720014500103.

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Model-based analysis of routinely generated pharmacokinetic and pharmacodynamic (PK–PD) data is a key component of preclinical drug discovery. The work process of such analyses can be automated by properly designed computer programs that reduce the number of manual steps, resulting in time saving and significantly fewer errors. Critical decisions can still be made by modelers. Using concrete animal data examples this paper illustrates when, and demonstrates how, automated PK–PD approaches can be used and what benefits they offer to the modeling and simulation community. Specifically, we descri
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Zhang, Shuang, Min Zhang, Weiwei Wu, et al. "Preclinical characterization of Sintilimab, a fully human anti-PD-1 therapeutic monoclonal antibody for cancer." Antibody Therapeutics 1, no. 2 (2018): 65–73. http://dx.doi.org/10.1093/abt/tby005.

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ABSTRACT Background Programmed cell death 1 (PD-1) is an inhibitory immune checkpoint expressed on activatedT cells. Upon the formation of T cell receptor (TCR)-pMHC complexes, concomitant PD-1 ligation to its ligands programmed death-ligand 1 (PD-L1) or programmed death-ligand 2 (PD-L2) downregulates TCR signaling and effector function. Here we describe the preclinical characterization of Sintilimab, a fully human IgG4 antibody that potently blocks PD-1 interactions with PD-L1 and PD-L2. Methods The binding affinity and blockade function were detected by using surface plasmon resonance (SPR),
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Dissertations / Theses on the topic "Preclinical PK/PD"

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SALVADORI, MICHELA. "Sviluppo di un nuovo modello preclinico farmacocinetico - farmacodinamico per la biodistribuzione delle cellule mesenchimali stromali (MSC)." Doctoral thesis, Università degli studi di Modena e Reggio Emilia, 2020. http://hdl.handle.net/11380/1200059.

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Le cellule mesenchimali stromali / staminali (MSC) rappresentano una promessa terapeutica nelle terapie cellulari e geniche. Nonostante decenni di ricerca preclinica, la mancanza di modelli farmacocinetici (PK) e farmacodinamici (PD) consolidati sta ostacolando una solida traslazione clinica di MSC nei pazienti. Il modello farmacocinetico-farmacodinamico (PK-PD) basato sul meccanismo è un approccio matematico adottato di routine dai farmacocinetisti preclinici per simulare il profilo PK / PD di un candidato composto allo sviluppo clinico e per prevedere il regime di dosaggio clinico. I modelli
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Book chapters on the topic "Preclinical PK/PD"

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Weber, Willi. "Typical PK/PD Approaches in Preclinical and Clinical Development." In Drug Discovery and Evaluation: Safety and Pharmacokinetic Assays. Springer International Publishing, 2024. http://dx.doi.org/10.1007/978-3-030-73317-9_51-1.

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Weber, Willi. "Typical PK/PD Approaches in Preclinical and Clinical Development." In Drug Discovery and Evaluation: Safety and Pharmacokinetic Assays. Springer International Publishing, 2024. http://dx.doi.org/10.1007/978-3-031-35529-5_51.

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Weber, Willi. "Typical PK/PD Approaches in Preclinical and Clinical Development." In Drug Discovery and Evaluation: Safety and Pharmacokinetic Assays. Springer Berlin Heidelberg, 2013. http://dx.doi.org/10.1007/978-3-642-25240-2_51.

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Chen, Xi, and Weirong Wang. "Mechanism and Physiologically Based PK/PD Model in Assisting Translation from Preclinical to Clinical: Understanding PK/PD of Therapeutic Proteins at Site-of-Action." In Quantitative Pharmacology and Individualized Therapy Strategies in Development of Therapeutic Proteins for Immune-Mediated Inflammatory Diseases. John Wiley & Sons, Inc., 2019. http://dx.doi.org/10.1002/9781119289234.ch3.

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Montanaro, Rosangela, Francesco Maione, and Vincenzo Brancaleone. "Activity Methods For Animal Pharmacokinetic and Pharmacodynamic Studies." In Methods for Preclinical Evaluation of Bioactive Natural Products. BENTHAM SCIENCE PUBLISHERS, 2023. http://dx.doi.org/10.2174/9789815123043123010012.

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This chapter provides an overview of the main features that need to be assessed with respect to the general pharmacology (pharmacokinetics, PK; pharmacodynamics, PD) of all molecules, including natural compounds. Here, the attention has been focused on bioavailability, the volume of distribution, and clearance to describe the physiological processes of absorption/distribution and elimination of drugs from the body. It is worth pointing out that PD studies always require an in vitro preliminary approach, not issued here, that needs to be assessed and confirmed in vivo. Indeed, PD studies aim to
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Walter, Sarah, Andrew Vick, Tom Hunter, et al. "Preclinical PK and PD Relationship for KAI-4169, a Novel Calcimimetic." In BASIC - Bone, Calciotropic Hormones & Vitamin D. The Endocrine Society, 2011. http://dx.doi.org/10.1210/endo-meetings.2011.part1.p9.p1-198.

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Conference papers on the topic "Preclinical PK/PD"

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Jumbe, Nelson L., William Fanslow, Sonal Patel, Benny Amore, Marc Retter, and Vincent Chow. "Abstract 3359: Translating preclinical PK/PD tumor volume modeling data to predict AMG172 PK and dose-escalation scheme in FIH." In Proceedings: AACR 104th Annual Meeting 2013; Apr 6-10, 2013; Washington, DC. American Association for Cancer Research, 2013. http://dx.doi.org/10.1158/1538-7445.am2013-3359.

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Feng, Ying, Yuqiao Shen, Don Musson, Huiyu Zhou, Oriane Scholler, and Leonard E. Post. "Abstract B67: Correlation of pharmacokinetics (PK), pharmacodynamics (PD) and in vivo antitumor activity of BMN 673 in preclinical models." In Abstracts: AACR-NCI-EORTC International Conference: Molecular Targets and Cancer Therapeutics--Nov 12-16, 2011; San Francisco, CA. American Association for Cancer Research, 2011. http://dx.doi.org/10.1158/1535-7163.targ-11-b67.

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Hall, Terence G., Ronald E. Savage, Brian Schwartz, et al. "Abstract B151: In FGFR2 driven tumors, preclinical pharmacokinetics (PK), pharmacodynamics (PD) and efficacy translate into clinical activity of ARQ 087." In Abstracts: AACR-NCI-EORTC International Conference: Molecular Targets and Cancer Therapeutics; November 5-9, 2015; Boston, MA. American Association for Cancer Research, 2015. http://dx.doi.org/10.1158/1535-7163.targ-15-b151.

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Knoerzer, Deborah, Martin Teresk, Peter Krutzik та ін. "Abstract B085: Preclinical pharmacokinetic/pharmacodynamic (PK/PD) relationship demonstrated for BVD-723, a potent and selective phosphoinositide 3-kinase gamma (PI3Kγ) inhibitor". У Abstracts: AACR-NCI-EORTC International Conference: Molecular Targets and Cancer Therapeutics; October 26-30, 2017; Philadelphia, PA. American Association for Cancer Research, 2018. http://dx.doi.org/10.1158/1535-7163.targ-17-b085.

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Kamerkar, Sushrut, Charan Leng, Kelvin Zhang, et al. "1344 Preclinical PK/PD profile, biomarker identification and rationale for indication selection of exoASO-STAT6™, a selective tumor-associated macrophage targeting candidate." In SITC 37th Annual Meeting (SITC 2022) Abstracts. BMJ Publishing Group Ltd, 2022. http://dx.doi.org/10.1136/jitc-2022-sitc2022.1344.

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Gutierrez, Pablo Morentin, Christopher Morrow, Natalie Cureton, et al. "Abstract 4369: Preclinical mechanistic PK/PD-efficacy modeling for AZD9833, a novel next generation oral SERD, to support dose selection during early clinical development." In Proceedings: AACR Annual Meeting 2020; April 27-28, 2020 and June 22-24, 2020; Philadelphia, PA. American Association for Cancer Research, 2020. http://dx.doi.org/10.1158/1538-7445.am2020-4369.

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Wittemer-Rump, Sabine, Anette Sommer, Charlotte Kopitz, et al. "Abstract 1683: Pharmacokinetic/pharmacodynamic (PK/PD) and toxicokinetic/toxicodynamic (TK/TD) modeling of preclinical data of FGFR2-ADC (BAY 1187982) to guide dosing in phase 1." In Proceedings: AACR 106th Annual Meeting 2015; April 18-22, 2015; Philadelphia, PA. American Association for Cancer Research, 2015. http://dx.doi.org/10.1158/1538-7445.am2015-1683.

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Wittemer-Rump, Sabine, Charlotte Kopitz, Hung Huynh, et al. "Abstract 672: Pharmacokinetic and pharmacodynamic (PK/PD) modeling of preclinical data of a novel anti-fibroblast growth factor receptor 2(FGFR2) antibody (BAY 1179470) to guide dosing in Phase 1." In Proceedings: AACR Annual Meeting 2014; April 5-9, 2014; San Diego, CA. American Association for Cancer Research, 2014. http://dx.doi.org/10.1158/1538-7445.am2014-672.

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Lum, Peggy, Juan Jose Perez Ruixo, Selam Ogbagabriel, et al. "Abstract B167: Identifying first in human (FIH) doses and schedule of U3‐1287 (AMG 888), a fully human anti‐HER3 mAb, based on preclinical pharmacokinetic (PK), pharmacodynamic (PD) and efficacy data." In Abstracts: AACR-NCI-EORTC International Conference: Molecular Targets and Cancer Therapeutics--Nov 15-19, 2009; Boston, MA. American Association for Cancer Research, 2009. http://dx.doi.org/10.1158/1535-7163.targ-09-b167.

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Aras, Urvi Telang, Deepika Lal, Patricia Zagst, Gerald J. Fetterly, and Eunice S. Wang. "Abstract 5463: Development of a pharmacokinetic (PK)-pharmacodynamic (PD) model to guide combination-dosing strategies of aflibercept (VEGF Trap) and doxorubicin chemotherapy in a systemic preclinical model of human acute myeloid leukemia." In Proceedings: AACR 102nd Annual Meeting 2011‐‐ Apr 2‐6, 2011; Orlando, FL. American Association for Cancer Research, 2011. http://dx.doi.org/10.1158/1538-7445.am2011-5463.

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