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Predicting efficacy assessment of combined treatment of radiotherapy and nivolumab for NSCLC patients through virtual clinical trials using QSP modeling J. Pharmacokinet. Pharmacodyn. (IF 2.5) Pub Date : 2024-03-17 Miriam Schirru, Hamza Charef, Khalil-Elmehdi Ismaili, Frédérique Fenneteau, Didier Zugaj, Pierre-Olivier Tremblay, Fahima Nekka
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An industry perspective on current QSP trends in drug development J. Pharmacokinet. Pharmacodyn. (IF 2.5) Pub Date : 2024-03-05
Abstract 2023 marks the 10th anniversary of Natpara’s submission to the US FDA, which led to the first recorded regulatory interaction where a decision was supported by Quantitative and Systems Pharmacology (QSP) simulations. It had taken about 5 years for the timid QSP discipline to emerge as an effective Model-Informed Drug Development (MIDD) tool with visible impact in the pharmaceutical industry
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Employing zero-inflated beta distribution in an exposure-response analysis of TYK2/JAK1 inhibitor brepocitinib in patients with plaque psoriasis J. Pharmacokinet. Pharmacodyn. (IF 2.5) Pub Date : 2024-03-03 Nikolaos Tsamandouras, Ruolun Qiu, Jim H. Hughes, Kevin Sweeney, John P. Prybylski, Christopher Banfield, Timothy Nicholas
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Fourteenth American Conference on Pharmacometrics (ACoP14) – Innovation and Diversity: Redefining Pharmacometrics J. Pharmacokinet. Pharmacodyn. (IF 2.5) Pub Date : 2024-02-28 Sihem Ait-Oudhia
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A minimal physiologically based pharmacokinetic model to study the combined effect of antibody size, charge, and binding affinity to FcRn/antigen on antibody pharmacokinetics J. Pharmacokinet. Pharmacodyn. (IF 2.5) Pub Date : 2024-02-24 Krutika Patidar, Nikhil Pillai, Saroj Dhakal, Lindsay B. Avery, Panteleimon D. Mavroudis
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Subgroup identification-based model selection to improve the predictive performance of individualized dosing J. Pharmacokinet. Pharmacodyn. (IF 2.5) Pub Date : 2024-02-24
Abstract Currently, model-informed precision dosing uses one population pharmacokinetic model that best fits the target population. We aimed to develop a subgroup identification-based model selection approach to improve the predictive performance of individualized dosing, using vancomycin in neonates/infants as a test case. Data from neonates/infants with at least one vancomycin concentration was randomly
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Thoughts on plagiarism and the case against Claudine Gay J. Pharmacokinet. Pharmacodyn. (IF 2.5) Pub Date : 2024-02-15 Peter L. Bonate
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Population pharmacokinetics of the dual endothelin receptor antagonist aprocitentan in subjects with or without essential or resistant hypertension J. Pharmacokinet. Pharmacodyn. (IF 2.5) Pub Date : 2024-02-08 Janneke M. Brussee, Patricia N. Sidharta, Jasper Dingemanse, Andreas Krause
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A population pharmacokinetics model of balovaptan to support dose selection in adult and pediatric populations J. Pharmacokinet. Pharmacodyn. (IF 2.5) Pub Date : 2024-02-03
Abstract Balovaptan is a brain-penetrating vasopressin receptor 1a antagonist previously investigated for the core symptoms of autism spectrum disorder (ASD). A population pharmacokinetic (PK) model of balovaptan was developed, initially to assist clinical dosing for adult and pediatric ASD studies and subsequently for new clinical indications including malignant cerebral edema (MCE) and post-traumatic
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How drug onset rate and duration of action affect drug forgiveness J. Pharmacokinet. Pharmacodyn. (IF 2.5) Pub Date : 2024-01-10 Elias D. Clark, Sean D. Lawley
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Semi-mechanistic modeling of resistance development to β-lactam and β-lactamase-inhibitor combinations J. Pharmacokinet. Pharmacodyn. (IF 2.5) Pub Date : 2023-11-26 Sebastian T. Tandar, Linda B.S. Aulin, Eva M. J. Leemkuil, Apostolos Liakopoulos, J. G. Coen van Hasselt
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Comparison of monoclonal antibody disposition predictions using different physiologically based pharmacokinetic modelling platforms J. Pharmacokinet. Pharmacodyn. (IF 2.5) Pub Date : 2023-11-12 Pieter-Jan De Sutter, Elke Gasthuys, An Vermeulen
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Evaluation of prompt engineering strategies for pharmacokinetic data analysis with the ChatGPT large language model J. Pharmacokinet. Pharmacodyn. (IF 2.5) Pub Date : 2023-11-11 Euibeom Shin, Murali Ramanathan
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Characterization of anti-drug antibody dynamics using a bivariate mixed hidden-markov model by nonlinear-mixed effects approach J. Pharmacokinet. Pharmacodyn. (IF 2.5) Pub Date : 2023-11-09 Ari Brekkan, Rocío Lledo-Garcia, Brigitte Lacroix, Siv Jönsson, Mats O. Karlsson, Elodie L. Plan
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Expansion of platform physiologically-based pharmacokinetic model for monoclonal antibodies towards different preclinical species: cats, sheep, and dogs J. Pharmacokinet. Pharmacodyn. (IF 2.5) Pub Date : 2023-11-10 Hsien-Wei Huang, Shengjia Wu, Ekram A. Chowdhury, Dhaval K. Shah
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Explaining in-vitro to in-vivo efficacy correlations in oncology pre-clinical development via a semi-mechanistic mathematical model J. Pharmacokinet. Pharmacodyn. (IF 2.5) Pub Date : 2023-11-06 Heinrich J. Huber, Hitesh B. Mistry
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Rare oncology therapeutics: review of clinical pharmacology package of drug approvals (2019–2023) by US FDA, best practices and recommendations J. Pharmacokinet. Pharmacodyn. (IF 2.5) Pub Date : 2023-11-04 Amitava Mitra, Jong Bong Lee, Douglas Steinbach, Anasuya Hazra, Rajesh Krishna
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Population pharmacokinetics and pharmacodynamics of efmarodocokin alfa (IL-22Fc) J. Pharmacokinet. Pharmacodyn. (IF 2.5) Pub Date : 2023-10-20 Yanke Yu, Michael E. Rothenberg, Han Ting Ding, Ari Brekkan, Gizette Sperinde, Brandon Harder, Rong Zhang, Ryan Owen, Nastya Kassir, Annemarie N. Lekkerkerker
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Learning pharmacometric covariate model structures with symbolic regression networks J. Pharmacokinet. Pharmacodyn. (IF 2.5) Pub Date : 2023-10-21 Ylva Wahlquist, Jesper Sundell, Kristian Soltesz
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Prospective approaches to gene therapy computational modeling – spotlight on viral gene therapy J. Pharmacokinet. Pharmacodyn. (IF 2.5) Pub Date : 2023-10-17 Mary P Choules, Peter L. Bonate, Nakyo Heo, Jared Weddell
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Low-dimensional neural ODEs and their application in pharmacokinetics J. Pharmacokinet. Pharmacodyn. (IF 2.5) Pub Date : 2023-10-14 Dominic Stefan Bräm, Uri Nahum, Johannes Schropp, Marc Pfister, Gilbert Koch
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Towards a platform quantitative systems pharmacology (QSP) model for preclinical to clinical translation of antibody drug conjugates (ADCs) J. Pharmacokinet. Pharmacodyn. (IF 2.5) Pub Date : 2023-10-03 Bruna Scheuher, Khem Raj Ghusinga, Kimiko McGirr, Maksymilian Nowak, Sheetal Panday, Joshua Apgar, Kalyanasundaram Subramanian, Alison Betts
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Physiologically based pharmacokinetic model to predict drug–drug interactions with the antibody–drug conjugate enfortumab vedotin J. Pharmacokinet. Pharmacodyn. (IF 2.5) Pub Date : 2023-08-26 Mary P. Choules, Peiying Zuo, Yukio Otsuka, Amit Garg, Mei Tang, Peter Bonate
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Training the next generation of pharmacometric modelers: a multisector perspective J. Pharmacokinet. Pharmacodyn. (IF 2.5) Pub Date : 2023-08-13 Peter L. Bonate, Jeffrey S. Barrett, Sihem Ait-Oudhia, Richard Brundage, Brian Corrigan, Stephen Duffull, Marc Gastonguay, Mats O. Karlsson, Shinichi Kijima, Andreas Krause, Mark Lovern, Michael Neely, Daniele Ouellet, Elodie L. Plan, Gauri G. Rao, Joseph Standing, Justin Wilkins, Hao Zhu
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Population pharmacokinetic/pharmacodynamic modeling of nifekalant injection with varies dosing plan in Chinese volunteers: a randomized, blind, placebo-controlled study J. Pharmacokinet. Pharmacodyn. (IF 2.5) Pub Date : 2023-08-11 Juanjuan Jiang, Li Xu, Lin Chai, Li Zhang, Hong Liu, Yan Yan, Xiaoyuan Guan, Hui Sun, Lei Tian
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Optimal sample selection applied to information rich, dense data J. Pharmacokinet. Pharmacodyn. (IF 2.5) Pub Date : 2023-08-10 David Wang, Tak Hung, Noelyn Hung, Paul Glue, Chris Jackson, Stephen Duffull
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Translational physiologically-based pharmacokinetic model for ocular disposition of monoclonal antibodies J. Pharmacokinet. Pharmacodyn. (IF 2.5) Pub Date : 2023-08-09 Sanika Naware, David Bussing, Dhaval K. Shah
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Population pharmacokinetic modeling and dosing simulation of avalglucosidase alfa for selecting alternative dosing regimen in pediatric patients with late-onset pompe disease J. Pharmacokinet. Pharmacodyn. (IF 2.5) Pub Date : 2023-08-03 Gilles Tiraboschi, David Marchionni, Gilles Tuffal, David Fabre, Jean-Marie Martinez, Kristina An Haack, Patrick Miossec, Barbara Kittner, Nadia Daba, Fabrice Hurbin
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Computational neurosciences and quantitative systems pharmacology: a powerful combination for supporting drug development in neurodegenerative diseases J. Pharmacokinet. Pharmacodyn. (IF 2.5) Pub Date : 2023-07-28 Hugo Geerts, Silke Bergeler, William W. Lytton, Piet H. van der Graaf
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Go beyond the limits of genetic algorithm in daily covariate selection practice J. Pharmacokinet. Pharmacodyn. (IF 2.5) Pub Date : 2023-07-26 D. Ronchi, E. M. Tosca, R. Bartolucci, P. Magni
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Generation and application of avatars in pharmacometric modelling J. Pharmacokinet. Pharmacodyn. (IF 2.5) Pub Date : 2023-07-24 Estelle Chasseloup, Andrew C. Hooker, Mats O. Karlsson
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International society of Pharmacometrics Mentorship Program (IMP): feedback survey from the first cohort of mentor-mentee pairs J. Pharmacokinet. Pharmacodyn. (IF 2.5) Pub Date : 2023-07-22 Patrick O. Hanafin, Ananya Murthy, Dhananjay Marathe, John K. Diep, Anu Shilpa Krishnatry, Hoi-Kei Lon, Dhaval K. Shah, Sihem Ait-Oudhia, Gauri G. Rao
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A two-stages global sensitivity analysis by using the δ sensitivity index in presence of correlated inputs: application on a tumor growth inhibition model based on the dynamic energy budget theory J. Pharmacokinet. Pharmacodyn. (IF 2.5) Pub Date : 2023-07-09 Alessandro De Carlo, Elena Maria Tosca, Nicola Melillo, Paolo Magni
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Classical structural identifiability methodology applied to low-dimensional dynamic systems in receptor theory J. Pharmacokinet. Pharmacodyn. (IF 2.5) Pub Date : 2023-06-30 Carla White, Vivi Rottschäfer, Lloyd Bridge
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Assessing the performance of QSP models: biology as the driver for validation J. Pharmacokinet. Pharmacodyn. (IF 2.5) Pub Date : 2023-06-29 Fulya Akpinar Singh, Nasrin Afzal, Shepard J. Smithline, Craig J. Thalhauser
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Clinical validation of translational antibody PBPK model using tissue distribution data generated with 89Zr-immuno-PET imaging J. Pharmacokinet. Pharmacodyn. (IF 2.5) Pub Date : 2023-06-29 Shufang Liu, Zhe Li, Marc Huisman, Dhaval K. Shah
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Physiologically-based pharmacokinetic modeling to predict drug-drug interaction of enzalutamide with combined P-gp and CYP3A substrates J. Pharmacokinet. Pharmacodyn. (IF 2.5) Pub Date : 2023-06-21 Yukio Otsuka, Srinivasu Poondru, Peter L. Bonate, Rachel H. Rose, Masoud Jamei, Fumihiko Ushigome, Tsuyoshi Minematsu
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Challenges, approaches and enablers: effectively triangulating towards dose selection in pediatric rare diseases J. Pharmacokinet. Pharmacodyn. (IF 2.5) Pub Date : 2023-06-09 Chandrasekar Durairaj, Indranil Bhattacharya
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Population pharmacokinetic and pharmacokinetic-pharmacodynamic modeling of bempedoic acid and low-density lipoprotein cholesterol in healthy subjects and patients with dyslipidemia J. Pharmacokinet. Pharmacodyn. (IF 2.5) Pub Date : 2023-05-27 Satyawan B. Jadhav, Benny M. Amore, Howard Bockbrader, Ryan L. Crass, Sunny Chapel, William J. Sasiela, Maurice G. Emery
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Empirical bayes approach for dynamic bayesian borrowing for clinical trials in rare diseases J. Pharmacokinet. Pharmacodyn. (IF 2.5) Pub Date : 2023-05-06 Bernard Sebastien
Application of Bayesian methods is one the tools that can be used to face the multiple challenges that are met when clinical trials must be conducted in rare diseases. We propose in this work to use a dynamic Bayesian borrowing approach, based on a mixture prior, to complement the control arm of a comparative trial and estimate the mixture parameter by an Empirical Bayes approach. The method is compared
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Achieving big with small: quantitative clinical pharmacology tools for drug development in pediatric rare diseases J. Pharmacokinet. Pharmacodyn. (IF 2.5) Pub Date : 2023-05-04 Mariam A. Ahmed, Janelle Burnham, Gaurav Dwivedi, Bilal AbuAsal
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The future of rare disease drug development: the rare disease cures accelerator data analytics platform (RDCA-DAP) J. Pharmacokinet. Pharmacodyn. (IF 2.5) Pub Date : 2023-05-02 Jeffrey S. Barrett, Alexandre Betourne, Ramona L. Walls, Kara Lasater, Scott Russell, Amanda Borens, Shlok Rohatagi, Will Roddy
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An integrated modelling approach for targeted degradation: insights on optimization, data requirements and PKPD predictions from semi- or fully-mechanistic models and exact steady state solutions J. Pharmacokinet. Pharmacodyn. (IF 2.5) Pub Date : 2023-04-29 Sofia Guzzetti, Pablo Morentin Gutierrez
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Special issue: Model-informed drug development in rare diseases: connecting the dots in an information rich ecosystem J. Pharmacokinet. Pharmacodyn. (IF 2.5) Pub Date : 2023-04-27 Rajesh Krishna
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External control arms for rare diseases: building a body of supporting evidence J. Pharmacokinet. Pharmacodyn. (IF 2.5) Pub Date : 2023-04-24 Artak Khachatryan, Stephanie H Read, Terri Madison
Comparator arms in randomized clinical trials may be impractical and/or unethical to assemble in rare diseases. In the absence of comparator arms, evidence generated from external control studies has been used to support successful regulatory submissions and health technology assessments (HTA). However, conducting robust and rigorous external control arm studies is challenging and despite all efforts
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Operational characteristics of full random effects modelling (‘frem’) compared to stepwise covariate modelling (‘scm’) J. Pharmacokinet. Pharmacodyn. (IF 2.5) Pub Date : 2023-04-21 Lisa F. Amann, Sebastian G. Wicha
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Joint longitudinal model-based meta-analysis of FEV1 and exacerbation rate in randomized COPD trials J. Pharmacokinet. Pharmacodyn. (IF 2.5) Pub Date : 2023-03-22 Carolina Llanos-Paez, Claire Ambery, Shuying Yang, Misba Beerahee, Elodie L. Plan, Mats O. Karlsson
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Implementation of non-linear mixed effects models defined by fractional differential equations J. Pharmacokinet. Pharmacodyn. (IF 2.5) Pub Date : 2023-03-21 Christos Kaikousidis, Aristides Dokoumetzidis
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An exploratory analysis of the performance of methylphenidate regimens based on a PKPD model of dopamine and norepinephrine transporter occupancy J. Pharmacokinet. Pharmacodyn. (IF 2.5) Pub Date : 2023-03-17 Sara Soufsaf, Philippe Robaey, Fahima Nekka
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Comparison of sequential and joint nonlinear mixed effects modeling of tumor kinetics and survival following Durvalumab treatment in patients with metastatic urothelial carcinoma J. Pharmacokinet. Pharmacodyn. (IF 2.5) Pub Date : 2023-03-12 Ting Chen, Yanan Zheng, Lorin Roskos, Donald E. Mager
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New Editorial Advisory Board Members and a Thank You. J. Pharmacokinet. Pharmacodyn. (IF 2.5) Pub Date : 2023-04-01
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Mechanistic incorporation of FcRn binding in plasma and endosomes in a whole body PBPK model for large molecules J. Pharmacokinet. Pharmacodyn. (IF 2.5) Pub Date : 2023-03-06 Wilhelmus E. A. de Witte, Lindsay B. Avery, Brian C. Mackness, Tom Van Bogaert, Anna Park, Maria Laura Sargentini-Maier
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A comprehensive regulatory and industry review of modeling and simulation practices in oncology clinical drug development J. Pharmacokinet. Pharmacodyn. (IF 2.5) Pub Date : 2023-03-04 Ana Ruiz-Garcia, Paul Baverel, Dean Bottino, Michael Dolton, Yan Feng, Ignacio González-García, Jaeyeon Kim, Seth Robey, Indrajeet Singh, David Turner, Shu-Pei Wu, Donghua Yin, Di Zhou, Hao Zhu, Peter Bonate
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Mechanistic inference of the metabolic rates underlying $$^{13}$$ C breath test curves J. Pharmacokinet. Pharmacodyn. (IF 2.5) Pub Date : 2023-02-15 Andrew F. Brouwer, Gwenyth O. Lee, Robert J. Schillinger, Christine A. Edwards, Hannah Van Wyk, Roger Yazbeck, Douglas J. Morrison
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A next generation mathematical model for the in vitro to clinical translation of T-cell engagers J. Pharmacokinet. Pharmacodyn. (IF 2.5) Pub Date : 2023-02-15 David Flowers, David Bassen, Georgi I. Kapitanov, Diana Marcantonio, John M. Burke, Joshua F. Apgar, Alison Betts, Fei Hua
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The role of quantitative systems pharmacology in pharmacometrics and the scope of the journal. J. Pharmacokinet. Pharmacodyn. (IF 2.5) Pub Date : 2023-02-01 Peter L Bonate
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Computing optimal drug dosing with OptiDose: implementation in NONMEM J. Pharmacokinet. Pharmacodyn. (IF 2.5) Pub Date : 2023-01-27 Freya Bachmann, Gilbert Koch, Robert J. Bauer, Britta Steffens, Gabor Szinnai, Marc Pfister, Johannes Schropp
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Pharmacokinetic comparability between two populations using nonlinear mixed effect models: a Monte Carlo study J. Pharmacokinet. Pharmacodyn. (IF 2.5) Pub Date : 2023-01-28 Siddhee A. Sahasrabudhe, Peter L. Bonate
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Changes in Associate Editors at the Journal of Pharmacokinetics and Pharmacodynamics. J. Pharmacokinet. Pharmacodyn. (IF 2.5) Pub Date : 2023-02-01 Peter L Bonate
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Latent variable indirect response modeling of clinical efficacy endpoints with combination therapy: application to guselkumab and golimumab in patients with ulcerative colitis J. Pharmacokinet. Pharmacodyn. (IF 2.5) Pub Date : 2023-01-17 Chuanpu Hu, Marion Vetter, An Vermeulen, Daniele Ouellet