Relevant bibliographies by topics / Preclinical PK

Contents

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

Academic literature on the topic 'Preclinical PK'

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

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Journal articles on the topic "Preclinical PK"

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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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Heller, A. A., S. Y. Lockwood, T. M. Janes, and D. M. Spence. "Technologies for Measuring Pharmacokinetic Profiles." Annual Review of Analytical Chemistry 11, no. 1 (2018): 79–100. http://dx.doi.org/10.1146/annurev-anchem-061417-125611.

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The creation of a pharmacokinetic (PK) curve, which follows the plasma concentration of an administered drug as a function of time, is a critical aspect of the drug development process and includes such information as the drug's bioavailability, clearance, and elimination half-life. Prior to a drug of interest gaining clearance for use in human clinical trials, research is performed during the preclinical stages to establish drug safety and dosing metrics from data obtained from the PK studies. Both in vivo animal models and in vitro platforms have limitations in predicting human reaction to a
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Ge, Yun-Xuan, Zhuo Zhang, Jia-Yi Yan, et al. "Prediction of Human Pharmacokinetics of E0703, a Novel Radioprotective Agent, Using Physiologically Based Pharmacokinetic Modeling and an Interspecies Extrapolation Approach." International Journal of Molecular Sciences 25, no. 5 (2024): 3047. http://dx.doi.org/10.3390/ijms25053047.

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E0703, a new steroidal compound optimized from estradiol, significantly increased cell proliferation and the survival rate of KM mice and beagles after ionizing radiation. In this study, we characterize its preclinical pharmacokinetics (PK) and predict its human PK using a physiologically based pharmacokinetic (PBPK) model. The preclinical PK of E0703 was studied in mice and Rhesus monkeys. Asian human clearance (CL) values for E0703 were predicted from various allometric methods. The human PK profiles of E0703 (30 mg) were predicted by the PBPK model in Gastro Plus software 9.8 (SimulationsPl
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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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Wang, Yang, Lu Zhang, Shuang Gu, et al. "The Current Application of LC-MS/MS in Pharmacokinetics of Traditional Chinese Medicines (Recent Three Years): A Systematic Review." Current Drug Metabolism 21, no. 12 (2020): 969–78. http://dx.doi.org/10.2174/1389200221666201009142418.

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Background: With significant clinical effects, traditional Chinese medicine (TCM) has been attracting increasing interest of the world’s scientific community. However, TCM contains immense amounts of chemical components. It is a great challenge to objectively evaluate the correlation between the in vivo process and the therapeutic effect of TCM. The purpose of this systematic review was to summarize the recent investigation (from 2017 to 2019) on preclinical pharmacokinetics (PK) of TCM via liquid chromatography coupled with mass spectrometry (LC-MS/MS). Method: We reviewed the published artic
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Patel, Chirag G., Mayank Patel, Arijit Chakravarty, et al. "Clinical pharmacokinetics (PK) and translational PK-pharmacodynamic (PD) modeling and simulation to predict antitumor response of various dosing schedules to guide the selection of a recommended phase II dose (RP2D) and schedule for the investigational agent MLN0128." Journal of Clinical Oncology 31, no. 15_suppl (2013): 2567. http://dx.doi.org/10.1200/jco.2013.31.15_suppl.2567.

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2567 Background: MLN0128 (INK128) is an investigational oral, potent, and highly selective inhibitor of mammalian target of rapamycin complex 1 and 2 (mTORC1/2) currently in clinical investigation. In the phase1 study INK128-001, MLN0128 was administered once daily (QD), once weekly (QW), QDx3D/week, and QDx5D/week, with respective MTDs of 6, 40, 16, and 10 mg. To guide selection of dose/schedule for further investigation, PD modulation in skin (pS6, p4EBP1, pNDRG1, pPRAS40) was put into context of clinical PK in INK128-001. A preclinical translational dynamic-PK efficacy model was used to des
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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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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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Singh, Dharaminder, Sudhir P. Deosarkar, Elaine Cadogan, et al. "A microfluidic system that replicates pharmacokinetic (PK) profiles in vitro improves prediction of in vivo efficacy in preclinical models." PLOS Biology 20, no. 5 (2022): e3001624. http://dx.doi.org/10.1371/journal.pbio.3001624.

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Test compounds used on in vitro model systems are conventionally delivered to cell culture wells as fixed concentration bolus doses; however, this poorly replicates the pharmacokinetic (PK) concentration changes seen in vivo and reduces the predictive value of the data. Herein, proof-of-concept experiments were performed using a novel microfluidic device, the Microformulator, which allows in vivo like PK profiles to be applied to cells cultured in microtiter plates and facilitates the investigation of the impact of PK on biological responses. We demonstrate the utility of the device in its abi
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Liu, Bo, Jonathan Chang, William P. Gordon, John Isbell, Yingyao Zhou, and Tove Tuntland. "Snapshot PK: a rapid rodent in vivo preclinical screening approach." Drug Discovery Today 13, no. 7-8 (2008): 360–67. http://dx.doi.org/10.1016/j.drudis.2007.10.014.

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Dissertations / Theses on the topic "Preclinical PK"

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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"

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Boroujerdi, Mehdi. "Practical Application of Pk/TK Models: Preclinical PK/TK and Clinical Trial." In Handbook of Pharmacokinetics and Toxicokinetics, 2nd ed. CRC Press, 2023. http://dx.doi.org/10.1201/9781003260660-21.

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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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"Preclinical PK/TK and Clinical Trials." In Pharmacokinetics and Toxicokinetics. CRC Press, 2015. http://dx.doi.org/10.1201/b18133-18.

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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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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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Conference papers on the topic "Preclinical PK"

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Casulleras, Maria Jove, Jade Spencer, Paul Loadman, et al. "Abstract 4926: Preclinical intratumoral pharmacokinetics (PK) of capecitabine (Cap) given +/- eribulin (Eri)." In Proceedings: AACR Annual Meeting 2018; April 14-18, 2018; Chicago, IL. American Association for Cancer Research, 2018. http://dx.doi.org/10.1158/1538-7445.am2018-4926.

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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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Dylgjeri, Emanuela, Jonathan F. Goodwin, Christopher M. McNair, et al. "Abstract LB-264: Preclinical evaluation of DNA-PK as a therapeutic target in prostate cancer." In Proceedings: AACR Annual Meeting 2017; April 1-5, 2017; Washington, DC. American Association for Cancer Research, 2017. http://dx.doi.org/10.1158/1538-7445.am2017-lb-264.

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Kadakia, Ekta, Natasha Iartchouk, Karuppiah Kannan, et al. "Abstract B154: Application of preclinical combination pharmacokinetic(PK)/efficacy(E) modeling to investigate and translate the preclinical scheduling effect for MLN1117 and Taxotere combination." 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-b154.

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Mignard, Caroline, Virginie Bari, Francis Bichat, Lucienne Cicurel, Grégoire Vuagniaux, and Maryse Barbier. "Abstract 571: PK and antitumor activity of DEBIO 0507, a new platinum derivative, in preclinical tumor models." In Proceedings: AACR 101st Annual Meeting 2010‐‐ Apr 17‐21, 2010; Washington, DC. American Association for Cancer Research, 2010. http://dx.doi.org/10.1158/1538-7445.am10-571.

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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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